510(k) K193038 ยท MBF Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented
Comprehensive Shoulder System
| Applicant | Biomet Manufacturing Corp, Warsaw IN, US |
| Decision | Substantially Equivalent, Oct 28, 2020 |
| Received | Oct 31, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K193038
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 20, 2025 | ZIMMER ORTHOPEDICS MANFACTURING LIMITED-GALWAY Comprehensive Shoulder Stem, Comprehensive Micro Stem, Comprehensive Mini Stem; uncemented shoulder prosthesis, Model Nos. 113605, 113606, 113607, 113627 Open, Classified |
MBF | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.