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Indications for Use Statement

510(k) Number (if known):____ K160655________________

Device Name: OrthoButton CL®

Indications for Use:

The Riverpoint Medical OrthoButton CL® is intended for use in the fixation of bone and soft tissue in
orthopedic procedures requiring ligament or tendon reconstruction.

Prescription Use ____X___ AND/OR Over-The-Counter Use

(Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

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