510(k) K181362 ยท JDC Prosthesis, Elbow, Constrained, Cemented
TEMA Elbow System
| Applicant | Lima Corporate S.P.A., Villanova Di San Daniele Del Friuli, IT |
| Decision | Substantially Equivalent, Feb 16, 2019 |
| Received | May 23, 2018 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K181362
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 16, 2023 | Limacorporate S.p.A TEMA Axle Small, REF 1590.15.010 (additional information is pending receipt of the firm's product label/labeling) Open, Classified |
JDC | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.