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Shoulder Prosthesis, Reverse Configuration

FDA product code PHX · 189 cleared devices

Class 2 Orthopedic
Regulation
21 CFR 888.3660
Review panel
OR
Implant
Yes
Life sustaining
No
Third party review
No
GMP exempt
No
Clearance span
2003-11-18 – 2026-07-01

Intended to be used to relieve pain and to replace the glenoid and humeral side of the shoulder joint in order to restore mobility in a grossly rotator cuff deficient joint with severe arthropathy or a previous joint replacement with a grossly rotator cuff deficient joint.

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