510(k) K900438 ยท JDI Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
MC2P ACETABULAR COMPONENT
| Applicant | Osteonics Corp., Allendale NJ, US |
| Decision | Substantially Equivalent, Apr 18, 1990 |
| Received | Jan 30, 1990 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K900438
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 16, 2026 | Howmedica Osteonics Corp. OMNIFIT SERIES I ACET. INSERT 10 22mm ID
Catalog No. 2001-2246
Orthopaedic implant components manufactured from UHMWPE (polyethylene) Open, Classified |
JDL | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.