510(k) K983502 ยท LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
OSTEONICS SECUR-FIT AD GENERATION II ACETABULAR COMPONENT SYSTEM
| Applicant | Osteonics Corp., Allendale NJ, US |
| Decision | Substantially Equivalent, Dec 16, 1998 |
| Received | Oct 6, 1998 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K983502
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 16, 2026 | Howmedica Osteonics Corp. TRIDENT 0 POLY INSERT 28mm ID
620-00-28D
Orthopaedic implant components manufactured from UHMWPE (polyethylene) Open, Classified |
MEH | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.