510(k) K163397 ยท MBF Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented
SMR Hybrid Glenoid System
| Applicant | Lima Corporate S.P.A., Villanova Di San Daniele Udine, IT |
| Decision | Substantially Equivalent, Jun 29, 2017 |
| Received | Dec 5, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K163397
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 1, 2023 | Limacorporate S.p.A SMR TT Hybrid glenoid Std - Peg S, REF: 1379.59.210 Open, Classified |
MBF | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.