510(k) K222427 ยท MBF Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented
PRIMA TT Glenoid
| Applicant | Lima Corporate S.P.A., Villanova Di San Daniele Del Friuli, IT |
| Decision | Substantially Equivalent, Oct 6, 2022 |
| Received | Aug 11, 2022 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K222427
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 12, 2024 | Limacorporate S.p.A PRIMA TT Glenoid Monoblock/Modular reverse TT baseplates: Description/Product Code:
BASEPLATE D.25MM REGULAR/1975.14.500,
BASEPLATE D.28MM REGULAR/1975.14.800,
BASEPLATE D.25MM FULL WEDGED 10-degrees/ Open, Classified |
MBF | None listed |
| Jun 27, 2023 | Limacorporate S.p.A REF 1975.14.500, Prima TT Genoid Monoblock Reverse TT Baseplate, STERILE R Open, Classified |
MBF | None listed |
| Jun 27, 2023 | Limacorporate S.p.A REF 1975.14.800, Prima TT Genoid Modular Reverse TT Baseplate, Sterile R Open, Classified |
MBF | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.