Panels › Orthopedic › Product code PAO · Class 2
Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer + Additive, Cemented
Regulation 888.3660
0510(k)s in 12 months (1 all time)
0recalls in 12 months (3 all time)
3recalls that name a 510(k)
Top companies in PAO
| Company | 510(k)s | Recalls |
|---|---|---|
| Tornier, Inc. | 1 | 1 |
| Biomet, Inc. | 0 | 1 |
| Zimmer Biomet, Inc. | 0 | 1 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 27, 2024 | Tornier, Inc Stryker Tornier Perform Humeral System, Reversed Insert, 45%, REF DWP2393, for shoulder arthroplasty Open, Classified |
PAO | K201315 |
| Feb 11, 2017 | Zimmer Biomet, Inc. Comprehensive Reverse Shoulder System Humeral Tray
Model 115340 Terminated |
PAO | K080642 |
| Jun 17, 2013 | Biomet, Inc. Superior Approach Resection Guide Assembly.
Indicated for primary, fracture, or revision total shoulder replacement for the relief of pain. Terminated |
PAO | K080642 |
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