510(k) K103233 ยท LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
MODULAR DUAL MOBILITY LINER, X3 ACETABULAR INSERT
| Applicant | Howmedica Osteonics Corp., Mahwah NJ, US |
| Decision | Substantially Equivalent, Feb 3, 2011 |
| Received | Nov 2, 2010 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K103233
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 16, 2011 | Stryker Howmedica Osteonics Corp. Stryker Modular Dual Mobility (MDM) Liner and X3 Acetabular Insert; Howmedica Osteonics Corp., 325 Corporate Drive, Mahwah, NJ 07430; Stryker France ZAC Satolos Green Pusignan Av de Satolas Green 6988 Terminated |
LZO | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.