510(k) K222807 ยท JDB Prosthesis, Elbow, Semi-Constrained, Cemented
TEMA Elbow system - Line extension
| Applicant | Lima Corporate S.P.A., Villanova Di San Daniele Del Friuli, IT |
| Decision | Substantially Equivalent, Oct 26, 2022 |
| Received | Sep 16, 2022 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K222807
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 20, 2024 | Limacorporate S.p.A TEMA Elbow - Axle Small REF 1590.15.010
TEMA Elbow - Axle Large REF 1590.15.020
TEMA Elbow System is a cemented total elbow prosthesis. Open, Classified |
JDB | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.