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Norm Posterior Occipital-


Cervical-Thoracic Spinal
Fixation System
Surgical Techniques

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Contents

Introduction
Implant Overview
Instrument Overview
Surgical Technique
1. Position the Patient and Approach
2. Cervico-Thoracic Fixation
3. Optional Techniques
4. Occipito-Cervical Fixation
5. Final Construct

Implants Size
Instrument Set

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Introduction
The Norm Posterior Occipital-Cervical-Thoracic Spinal Fixation System is a universal system

designated to facilitate reconstruction of the cervical and upper thoracic spine. The Norm

Posterıor Occipital-Cervical-Thoracic Spinal Fixation System provides a comprehensive

solution for a rigid posterior fixation of the Occipito-Cervico-Thoracic spine. Offering

exceptional versatility and ease-of-use, the Norm Posterıor Occipital-Cervical-Thoracic

Spinal Fixation System features:

• Top-loading Multi-Axial Screws to simplify construct assembly

• Friction fit Screws to maintain seat alignment and facilitate Rod insertion

• 3.5mm titanium alloy Rods and cobalt chrome Rod to maximize strength

• Occipital Plates with sliding connectors to ease rod engagement

Implant Overview

The Norm Posterıor Occipital-Cervical-Thoracic Spinal Fixation System includes polyaxial

screw different diameters and lengths. The System also offers a variety of implant options

including rod to rod transverse link, Ø3.5/5,5mm or Ø3.5/6.0mm rod connectors, pre-cut and

pre-bent Ø3.5mm Ti rods, Ø3.5mm to Ø6,0mm CoCr rods, Ø3.5/6.0mm transition rods,

lateral connectors, hooks, occipital plates and occipital plate screws.

The Norm Posterior Occipital-Cervical-Thoracic Spinal Fixation System instrumentation

allows the surgeon the flexibility to build a construct that meets anatomical challenges and

handles the pathology being treated. All implants in the Norm Posterior Occipital-Cervical-

Thoracic Spinal Fixation System (except the cobalt chrome rods) are manufactured from

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titanium alloy Ti 6Al-4V ELI. Rods are available in two different materials: titanium alloy

and cobalt chrome.

Figure:1 Norm Posterior Occipital-Cervical-Thoracic Spinal Fixation System

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Instrument Overview

OCCIPITO CERVICAL FIXTATION SYSTEM (OXIS)


CODE PRODUCT PRODUCT PICTURE UNIT

PCS001 DISTRACTOR 1

PCS002 COMPRESSOR 1

PCS003 PERSUADER 1

PCS004 ROD BENDER 1

PCS005 ROD CUTTER 1

PCS006 ROD AND LINK HOLDER 1

PCS007 3NM TORQUE 1

PCS008 L- TORQUE 1

PCS009 ROD PUSHER 1

PCS010 PROBE STRAIGHT 1

PCS011 AWL 1

PCS012 1/4 I HANDLE 2

PCS013 DRILL GUIDE 1

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PCS014 DRILL MEASURE STOPPER 1

PCS015 2,5 DRILL WITH STOPPER 1

PCS016 FEELER 1

PCS017 SET SCREW HOLDER 1

PCS018 SET SCREW DRIVER 1

PCS019 FIXED POLIAXIAL SCREW DRIVER 1

PCS020 TRANSVERSE SCREW DRIVER 1

PCS021 2.5 DRILL 1

PCS022 TAP 3.5M 1

PCS023 TAP 4.0MM 1

PCS024 POLYAXIAL SCREW DRIVER 2

PCS025 OXCIPITAL PLATE BENDER 2

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Surgical Technique

1. Position the patient and Approach

Preoperative planning is critical in the preparation for spinal surgery. Place the patient on a

radiolucent operating table in the prone position with the head and neck held securely in

proper alignment. Proper patient position should be confirmed via direct visualization and by

radiograph prior to draping. To complete a midline sub-peroisteal incision and dissection

down to the spinous processes of the appropriate vertebrae. Extend dissection laterally to

expose the facets and transverse processes.

In general the entrance of the pedicle is located at the intersection of a horizantal line parallel

to the upper 1/3 of the transverse process and a vertical line through the middle of the superior

facet.

Fig:2 Patient Position

2. Cervico-Thoracic Fixation

The Norm Posterior Occipital-Cervical-Thoracic Spinal Fixation System offers a variety of

stabilization options in the cervical and upper thoracic spine. The Polyaxial screws,

Transverse link, Lateral Connectors and Hooks are available to meet the needs of the most

challenging cases.

The following Surgical Technique outlines the recommended placement and use of Norm

Posterior Occipital-Cervical-Thoracic Spinal Fixation System components. Actual selection

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of system implants may vary from those described in this technique depending on procedural

and anatomical considerations.

2.1. Polyaxial Screw Placement

The Norm Posterior Occipital-Cervical-Thoracic Spinal Fixation System features top-loading

and top-tightening Polyaxial Screws. Preferred Angle Screws offer 45° in the preferred

direction and 28° in the standard direction. Standard Polyaxial Screws offer 56° of conical

angulation and have a friction-fit mechanism to maintain screw angulation during placement.

Please note that polyaxial Screws are intended for use in the upper thoracic spine.

Fig:3 Idendified Screw placement

2.2. Bone Awl

Penetrate the cortex of the bone with the PCS011 Awl. It is determined the entry point and

trajectory of the screw. The Awl contains a stop that limits insertion to 8.0mm. Creating a

pilot hole with the Awl penetrates the cortical bone, which will help prevent movement of the

Drill and Drill Guide during drilling. Repeat for all screw placement sites Determine Drill or

Probe penetration depth based on radiographic films or fluoroscopy.

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Fig 4: PCS011 Awl

2.3. Drill

Select the appropriate length of Fixed Depth Drill. Drills are available in lengths of 8mm-

32mm in 2.0mm increments and attach to the provided PCS012 ¼ Handle. An Adjustable

Depth Drill PCS014 is also included. After attaching the appropriate Drill Shaft PCS015 to

the ¼ Handle, align the Drill Guide with the pilot hole and maintain the desired drill

trajectory. Insert the Drill into the barrel of the Drill Guide and rotate clockwise while

advancing the drill down the Drill Guide. When using Fixed Depth Drills, the appropriate

depth is reached when the stop on the Drill shaft contacts the stop on the Drill Guide. When

using the Adjustable Depth Drill, the appropriate depth is reached when the desired depth

marking on the drill shaft aligns with the depth indicator line etched on the handle of the Drill

Guide. Once the desired depth is reached, gently remove the shaft of the Drill. PCS010 Probe

may be used to confirm that the drill hole remains within the confines of the bone. The depth

of the drill hole can be confirmed using the Depth Gauge by inserting the tip of the Depth

Gauge into the drill hole until the tip contacts the bottom of the hole. Repeat for all screw

placement sites.

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Fig.5: PCS012 ¼ I-Handle,PCS014 Depth Drill with Stopper PCS013 Drill Guide

2.4. Feeler

Use the PCS016 Feeler to evaluate the condition of the cortical wall of the pedicle. Apply the

appropriate probe and externally or internally palpate the wall or canal of the pedicle to ensure

the wall is not perforated.

Fig.6: PCS016 Feeler

2.5. Tap

Please note that Norm Posterior Occipital-Cervical-Thoracic Spinal Fixation System

Polyaxial Screws are self-tapping and that manual tapping may not be necessary. PCS022 and

PCS023 Taps are provided in 3.5mm, 4.0mm diameters. After attaching the tap Shaft to ¼

Handle tap to the appropriate depth. Repeat for all screw placement sites.

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Fig.7: PCS022 Tap 3,5mm PCS023 Tap 4,0mm and PCS012 ¼ I-Handle

2.6. Screw Selection

After drilling/tapping the hole, use the Depth Gauge to confirm the length of polyaxial screw

to be inserted. Screw length may be confirmed using the gauge located on the screw caddy.

Fig.8: Screw Caddy

2.7. Polyaxial Screw Insertion

After confirming the appropriate screw length, place the PCS024 Polyaxial Screw Driver

securely into the PCS012 ¼ I- Handle. Attach the approprite polyaxial screw to the screw

driver. Insert the polyaxial screw driver into the previously drilled/tapped hole by rotating the

driver clockwise to gently advance the screw to the desired depth. Once the desired depth is

reached, disengage the polyaxial screw driver from the loaded Screw by rotating the threaded

collar on the shaft counter clockwise until the driver is completely disengaged. If the anatomy

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requires the preferred angle to face medially or laterally, a lateral connector can be utilized for

proper seating of the screw. Repeat for all screw placement sites.

Fig.9 PCS024 Polyaxial Screw Driver with PCS012 ¼ I- Handle

Note: The screw should extend approximately %50 to %80 into vertebralbody and should not

create soft tissue impingement at closure. PCS019 Fixed polyaxial screw driver use to adjust

the sagittal height of the polyaxial screw and the screws head adjuster to aligh the saddles of

the polyaxial screws

. Fig.10: PCS024 Polyaxial Screw Driver with

PCS012 ¼ I- Handle

2.8. Rod Preparation

The Rod may be used to determine the appropriate length and curvature of the Rod. Cut the

Rod to the appropriate length using the PCS005 Rod Cutter and contour the rod to the

appropriate shape using the PCS004 Rod Bender.

Do not straighten the rod after bending.

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Fig.11: PCS005 Rod Cutter and PCS004 Rod Bender

2.9. Rod Insertion

Orient the screws so that the screw saddles are in the longitudinal palne. Once positing is

achieved place the rod in the screw saddles by PCS006 Rod holder. The Rod Reducer or

Persuader may be used if additional assistance is required to fully position the rod into the

seat of the Screw or Hook.

Fig.12: PCS006 Rod Holder

2.10. Set Screws Placement

Use the PCS017 Set Screw Holder to position and tighten the set screw on the polyaxial

screw. Seat the rod fully in the screw saddle with the aid of the PCS009 Rod pusher and

PCS003 Persuader. Rod reducer is used to seat the rod into the screws saddle for subsequent

set screw placement.

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Fig.13: PCS017 Set Screw Holder PCS003 Persuader PCS009 Rod pusher PCS018 Set Screw

Driver

Fig.13: PCS018 Set Screw Driver and PCS012 ¼ I-

Handle

2.11. Screw Positioning

The PCS001 Compressor and PCS002 Distractor may be used to perform minor screw

adjustments.

Fig.14: PCS001 Compressor and PCS002 Distractor

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2.12. Final Tightening

To maintain torsional stability of the construct, the PCS007 3NM Torque, PCS008 L-Anti

Torque and PCS018 Set Screw Driver must be used during final tightening of The Norm

Posterior Occipital-Cervical-Thoracic Spinal Fixation System constructs both screws and

hooks.

Attach the PCS018 Set Screw Driver to PCS007 3NM Torque, Anti Torque handle is fully

seated over the screws and rod. Rotate the handle clockwise until an audible click is heard and

tension is released within the handle

Fig.15 PCS007 3NM Torque, PCS008 L-Anti

Torque and PCS018 Set Screw Driver

3. Optional Techniques

3.1. Linkage to other NORM Posterior Systems

Transitional Rods and Rod domino connector are available to link the Norm Posterior cervical

System with other NORM Posterior Systems. Transitional Rods and Rod Connectors are

offered in 3.5mm/5,5mm and 3.5mm/6,0mm sizes.

Fig.16 Domino Connector

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3.2. Cross Connector Placement

Select the appropriate transverse link and position on the rod by PCS006 Rod and Link

holder. Lock the transverse link connectors into position using the PCS020 Fixed Set Screw

Driver.

Fig.18: PCS006 Rod and Link holder, PCS020 Fixed Set Screw Driver

3.3. Hook Insertion

The Norm Posterior OXIS System offers both 4.5mm Standard and 6.0mm Extended Hook

sizes. Both are top-loading and top-tightening for easy insertion and tightening determine the

size of Hook required. Secure the Hook to the Hook Inserter by rotating the threaded collar on

the Hook Inserter shaft clockwise until the shaft is completely engaged with the seat of the

Hook. The Hook Site Elevator may be used to elevate the lamina during Hook insertion.

Insert the Hook onto the lamina using the Hook Inserter.

Once the hook is inserted, disengage the Hook from the Hook Inserter by rotating the

threaded collar on the Hook Inserter shaft counterclockwise until the Hook is completely

disengaged. Repeat for all Hook placement sites.

Fig.19: Hook

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4. Occipito-Cervical Fixation

The Norm Posterior Occipital Plate offers low-profile fixation along the midline of the

occiput, where the most bone purchase can be obtained.

When positioning the occipital plate, it should be centered on the midline between the

External Occipital Protuberance (EOP) and the posterior border of the foramen magnum. The

goal is to maximize bone purchase (closer to EOP) while achieving a low profile. The Norm

Posterior Occipital System offers three occipital plates to accommodate patient anatomy: 45-

50-55mm

Each plate size has three midline holes for occipital fixation. Placement of as many screws as

possible is recommended. A minimum of two screws must be used; a minimum of three

screws must be used if the plate is bent, including one screw in the superior hole. The

occipital plates include rod connector housings that rotate up to 40° to ease rod placement.

The Norm Posterior Occipital System occipital screws are available in diameters of 3,5mm

and 4,0mm.

Once an appropriate size Plate has been selected, gently bend the Plate to the appropriate

Radius by PCS025 Occipital plate bender.

Do not bend the Plate near the sliding connectors. Do not straighten the Plate after bending.

Fig.20 Occipital Plate Selection and PCS025 Occipital plate bender

4.1. Awl

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Mark the entry points where the Occipital Bone Screws will be inserted through the holes in

the Occipital Plate by PCS011 Awl. The Occipital Plate should sit flush against the occiput.

It may be necessary to remove small amounts of occipital bone to optimize the plate-to-bone

interface. Do not remove bone near areas of screw placement.

Determine the lengths of Occipital Bone Screws required via preoperative planning or

fluoroscopy.

Fig.21: PCS011 Awl

4.2.Drill

Attach the PCS015 Depth Drill shaft with PCS Depth drill stopper to PCS012 1/4 I- Handle

Slide the adjustable drill stop over the drill. PSC013 Drill Guide. Place the appropriate drill

into the modular handle. Set the drill stop to appropriate drilling depth. .Repeat for all screw

placement sites.

Note: The depth gauge measures the working length. If reading e.g. 10 mm on the depth

gauge, select a 10 mm screw.

Warning: Do not insert depth gauge too deep in order to confirm correct hole depth and to

avoid damage to soft tissue.

Fig.22 PCS014 Occipital Drill shaft to PCS012 1/4 I- Handle

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4.3. Tap

Attach the PCS022 Tap 3,5 or PCS023 Tap 4,0 mm to PCS012 ¼ I- Handle and tap to the

appropriate depth.

Note: Tapping is recommended for all screws

Fig.23: PCS022 Tap 3,5 or PCS023 Tap 4,0 mm PCS012 ¼ I- Handle

4.4.Plate And Screw Insertion

Attach the PCS019 Fixed Screw Driver to a PCS012 I-Handle and place the occipital plate

into its previously determined position. Attach the appropriate length occipital bone screws to

the occipital bone screws driver. Insert the occipital bone screw into the prepared hole locking

the occipital plate into position. Place the remaining screws using the same way.

Fig.24: PCS019 Fixed Screw Driver,PCS012 I-

Handle

4.5.Rod Preparation And Insertion

Cut the Rod to the appropriate length using the Rod Cutter and contour the Rod to the

appropriate shape using the Rod Bender. Do not straighten the Rod after bending.

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Insert the Rod into the rod channel sliding connectors of the Occipital Plate so that

approximately 3.0mm-4.0mm of the Rod extends above the channel. Repeat for all Rods.

Fig.25: PCS004 Rod Bender

4.6.Set Screws Insertion

Insert the Set Screws into the seat(s) by using PCS017 Set Screws Holder and respectively,

and provisionally tighten provisionally the PCS018 Set screws driver attached to a PCS012 I-

Handle Repeat for the contralateral side.

Fig.26: PCS018 Set screws driver and PCS012 I-Handle

4.7.Final Tightening

Position the PCS008 L- Torque over the set screw and rod. Place the PCS018 Set screws

torque driver with attached PCS007 3nm Torque, securely into the set screw. Turn the toorgue

driver clockwise to tigten the set screws.

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.

Fig.27: PCS008 L- Torque PCS007 3nm Torque PCS018 Set screws torque driver

5. Final construction

Turn the torque driver clockwise to tigten the all set screws.

Fig:28 Final contruction

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Implant Size

Posterior Occipital-Cervical-Thoracic Spinal Fixation System


CODE PRODUCT NAME SIZE
NPCSS3508 TITANIUM POLYAXIAL SCREW + SET SCREW 3.5 X 08 MM
NPCSS3510 TITANIUM POLYAXIAL SCREW + SET SCREW 3.5 X 10 MM
NPCSS3512 TITANIUM POLYAXIAL SCREW + SET SCREW 3.5 X 12 MM
NPCSS3514 TITANIUM POLYAXIAL SCREW + SET SCREW 3.5 X 14 MM
NPCSS3516 TITANIUM POLYAXIAL SCREW + SET SCREW 3.5 X 16 MM
NPCSS3518 TITANIUM POLYAXIAL SCREW + SET SCREW 3.5 X 18 MM
NPCSS3520 TITANIUM POLYAXIAL SCREW + SET SCREW 3.5 X 20 MM
NPCSS3522 TITANIUM POLYAXIAL SCREW + SET SCREW 3.5 X 22 MM
NPCSS3524 TITANIUM POLYAXIAL SCREW + SET SCREW 3.5 X 24 MM
NPCSS4008 TITANIUM POLYAXIAL SCREW + SET SCREW 4.0 X 08 MM
NPCSS4010 TITANIUM POLYAXIAL SCREW + SET SCREW 4.0 X 10 MM
NPCSS4012 TITANIUM POLYAXIAL SCREW + SET SCREW 4.0 X 12 MM
NPCSS4014 TITANIUM POLYAXIAL SCREW + SET SCREW 4.0 X 14 MM
NPCSS4016 TITANIUM POLYAXIAL SCREW + SET SCREW 4.0 X 16 MM
NPCSS4018 TITANIUM POLYAXIAL SCREW + SET SCREW 4.0 X 18 MM
NPCSS4020 TITANIUM POLYAXIAL SCREW + SET SCREW 4.0 X 20 MM
NPCSS4022 TITANIUM POLYAXIAL SCREW + SET SCREW 4.0 X 22 MM
NPCSS4024 TITANIUM POLYAXIAL SCREW + SET SCREW 4.0 X 24 MM
NPCSS4026 TITANIUM POLYAXIAL SCREW + SET SCREW 4.0 X 26 MM
NPCSS4028 TITANIUM POLYAXIAL SCREW + SET SCREW 4.0 X 28 MM
NPCSS4030 TITANIUM POLYAXIAL SCREW + SET SCREW 4.0 X 30 MM
NPCSS4032 TITANIUM POLYAXIAL SCREW + SET SCREW 4.0 X 32 MM
NPCSS4034 TITANIUM POLYAXIAL SCREW + SET SCREW 4.0 X 34 MM
NPCSS4036 TITANIUM POLYAXIAL SCREW + SET SCREW 4.0 X 36 MM
NPCSS4038 TITANIUM POLYAXIAL SCREW + SET SCREW 4.0 X 38 MM
NPCSS4040 TITANIUM POLYAXIAL SCREW + SET SCREW 4.0 X 40 MM
NPCTOS3506 TITANIUM POSTERIOR CERVICAL PLATE SCREW 3.5 X 06 MM
NPCTOS3508 TITANIUM POSTERIOR CERVICAL PLATE SCREW 3.5 X 08 MM
NPCTOS3510 TITANIUM POSTERIOR CERVICAL PLATE SCREW 3.5 X 10 MM
NPCTOS3512 TITANIUM POSTERIOR CERVICAL PLATE SCREW 3.5 X 12 MM
NPCTOS3514 TITANIUM POSTERIOR CERVICAL PLATE SCREW 3.5 X 14 MM
NPCTOS3516 TITANIUM POSTERIOR CERVICAL PLATE SCREW 3.5 X 16 MM
NPCTOS3518 TITANIUM POSTERIOR CERVICAL PLATE SCREW 3.5 X 18 MM
NPCTOS3520 TITANIUM POSTERIOR CERVICAL PLATE SCREW 3.5 X 20 MM
NPCTOS4006 TITANIUM POSTERIOR CERVICAL PLATE SCREW 4.0 X 06 MM

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NPCTOS4008 TITANIUM POSTERIOR CERVICAL PLATE SCREW 4.0 X 08 MM
NPCTOS4010 TITANIUM POSTERIOR CERVICAL PLATE SCREW 4.0 X 10 MM
NPCTOS4012 TITANIUM POSTERIOR CERVICAL PLATE SCREW 4.0 X 12 MM
NPCTOS4014 TITANIUM POSTERIOR CERVICAL PLATE SCREW 4.0 X 14 MM
NPCTOS4016 TITANIUM POSTERIOR CERVICAL PLATE SCREW 4.0 X 16 MM
NPCTOS4018 TITANIUM POSTERIOR CERVICAL PLATE SCREW 4.0 X 18 MM
NPCTOS4020 TITANIUM POSTERIOR CERVICAL PLATE SCREW 4.0 X 20 MM
NPCHFL TITANIUM OCCIPITAL PLATE LARGE 45MM
NPCHFS TITANIUM OCCIPITAL PLATE SMALL 50MM
NPCHFM TITANIUM OCCIPITAL PLATE MEDIUM 55MM
NPCLH45 LAMINAR HOOK 4.5 MM
NPCLH60 LAMINAR HOOK 6.0 MM
NPCLHA18 18 DEGREE ANGLED HOOK 18 ANGLE
NPCLH405 LAMINAR HOOK 4X5 MM 4X5 MM
NPCLH406 LAMINAR HOOK 4X6 MM 4X6 MM
NPCLH407 LAMINAR HOOK 4X7 MM 4X7 MM
NPCLC10 LATERAL CONNECTOR 10 MM 10 MM
NPCLC12 LATERAL CONNECTOR 12 MM 12 MM
NPCRC3560 ROD CONNECTOR 3.5 - 6.0 MM
NPCRC3555 ROD CONNECTOR 3.5 - 5,5 MM
NPCRC3535 ROD CONNECTOR 3.5 - 3.5 MM
NPCTR12 TITANIUM ROD 3.5 X 120MM
NPCTR14 TITANIUM ROD 3.5 X 140MM
NPCTR18 TITANIUM ROD 3.5 X 180MM
NPCTR24 TITANIUM ROD 3.5 X 240MM
TITANIUM OCCIPITOCERVICAL ROD 150X70 45
NPCORA
ANGLED 150X70 45 ANGLED
NPCTL40 NORM POSTERIOR CERVICAL TRANSVERSE LINK 40MM
NPCTL50 NORM POSTERIOR CERVICAL TRANSVERSE LINK 50MM
NPCTL60 NORM POSTERIOR CERVICAL TRANSVERSE LINK 60MM
NPCTL70 NORM POSTERIOR CERVICAL TRANSVERSE LINK 70MM

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Instrument Set

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