510(k) K951671 ยท MEH Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate
OSTEONICS RESTORATION MONOLITHIC II SLOTTED HIP STEM SERIES
| Applicant | Osteonics Corp., Allendale NJ, US |
| Decision | Substantially Equivalent, Sep 6, 1995 |
| Received | Apr 11, 1995 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K951671
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 29, 2012 | Stryker Howmedica Osteonics Corp. Restoration HA Reduced Neck 255 mm Long Stem
Manufactured by Stryker Howmedica Osteonics Corp.
325 Corporate Drive
Mahwah, NJ 07430.
The Restoration HA cementless Hip System is designed to address t Terminated |
MEH | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.