510(k) K033634 ยท KWA Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component)
EPSILON METASUL 32MM ACETABULAR INSERTS, STANDARD AND HOODED
| Applicant | Centerpulse Orthopedics, Inc., Austin TX, US |
| Decision | Substantially Equivalent, Sep 15, 2004 |
| Received | Nov 19, 2003 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K033634
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 20, 2015 | Zimmer Gmbh Metasul Femoral Head - A modular head component is used in conjunction with a femoral stem component for replacement of the proximal femur in total hip arthroplasty. Terminated |
KWA | None listed |
| Sep 17, 2008 | Zimmer Inc. Zimmer Metasul Head 32/-4'S', taper 12/14, hip implant component; REF 19.32.05. Terminated |
KWA | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.