510(k) K980502 ยท JDC Prosthesis, Elbow, Constrained, Cemented
OSTEONICS TOTAL ELBOW SYSTEM
| Applicant | Osteonics Corp., Allendale NJ, US |
| Decision | Substantially Equivalent, May 5, 1998 |
| Received | Feb 9, 1998 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K980502
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 16, 2026 | Howmedica Osteonics Corp. AXLE PIN ASSY LARGE ELBOW COBALT CHROME
Catalog No. C-M112-2-500
Orthopaedic implant components manufactured from UHMWPE (polyethylene) Open, Classified |
JDC | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.