510(k) K212800 · PHX Shoulder Prosthesis, Reverse Configuration
PRIMA Humeral System and SMR Glenosphere Ø42
| Applicant | Lima Corporate S.P.A., Villanova Di San Daniele Del Friuli, IT |
| Decision | Substantially Equivalent, Feb 25, 2022 |
| Received | Sep 2, 2021 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K212800
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 25, 2025 | Limacorporate S.p.A PRIMA 2MM ECCENTRICAL ADAPTOR WITH SCREW REF: 1367.15.702, Sterile Open, Classified |
PHX | None listed |
| Jun 25, 2025 | Limacorporate S.p.A PRIMA 4MM ECCENTRICAL ADAPTOR WITH SCREW, REF:1367.15.704, Sterile Open, Classified |
PHX | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.