1 device · 1 company · 2026
Product code PHX: Shoulder Prosthesis, Reverse Configuration
1 device under product code PHX, 2026, from 1 company. Each record carries FDA's decision, the Indications for Use statement verbatim where the public document carries one (1 of 1 here), the regulation, and MAUDE report counts by product code.
Shoulder Prosthesis, Reverse Configuration. 21 CFR 888.3660, Class II. 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. MAUDE held 13,256 adverse-event reports against this product code as of 2026-10-29; reports are unverified and the code is shared by every device of this type.
Retrieved from FDA public records.
Every device, newest decision first
| Decision | Device | Company | Panel | FDA |
|---|---|---|---|---|
| Veritas Reverse Total Shoulder SystemK253992 · 510(k) | Restor3D | Orthopedic | database entry |
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