510(k) K030724 ยท LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
ALUMINA CERAMIC FEMORAL HEADS, 28 AND 32 MM
| Applicant | Zimmer, Inc., Warsaw IN, US |
| Decision | Substantially Equivalent, Jun 3, 2003 |
| Received | Mar 7, 2003 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K030724
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 27, 2009 | Zimmer Inc. Zimmer Alumina Ceramic Femoral Head, 12/14 taper, 32 mm diameter, neck length 0 mm, sterile, Zimmer, Warsaw, IN; Catalog Number: 6428-32-02.
Orthopedic implant used in total hip arthroplasty. Terminated |
LZO | None listed |
| Nov 21, 2008 | Zimmer Inc. Zimmer Alumina Ceramic Femoral Head, 12/14 taper, 28 mm diameter, neck length -3.5 mm, sterile, Zimmer, Warsaw, IN; REF 00-6418-028-01 and 00-6428-028-01.
The Alumina Ceramic Femoral Heads are modula Terminated |
LZO | None listed |
| Nov 21, 2008 | Zimmer Inc. Zimmer Alumina Ceramic Femoral Head, 12/14 taper, 28 mm diameter, neck length 0 mm, sterile, Zimmer, Warsaw, IN; REF 00-6418-028-02 and 00-6428-028-02.
The Alumina Ceramic Femoral Heads are modular c Terminated |
LZO | None listed |
| Nov 21, 2008 | Zimmer Inc. Zimmer Alumina Ceramic Femoral Head, 12/14 taper, 28 mm diameter, neck length +3.5 mm, sterile, Zimmer, Warsaw, IN; REF 00-6418-028-03 and 00-6428-028-03.
The Alumina Ceramic Femoral Heads are modula Terminated |
LZO | None listed |
| Nov 21, 2008 | Zimmer Inc. Zimmer Alumina Ceramic Femoral Head, 12/14 taper, 32 mm diameter, neck length -3.5 mm, sterile, Zimmer, Warsaw, IN; REF 00-6418-032-01 and 00-6428-032-01.
The Alumina Ceramic Femoral Heads are modula Terminated |
LZO | None listed |
| Nov 21, 2008 | Zimmer Inc. Zimmer Alumina Ceramic Femoral Head, 12/14 taper, 32 mm diameter, neck length 0 mm, sterile, Zimmer, Warsaw, IN; REF 00-6418-032-02 and 00-6428-032-02.
The Alumina Ceramic Femoral Heads are modular c Terminated |
LZO | None listed |
| Nov 21, 2008 | Zimmer Inc. Zimmer Alumina Ceramic Femoral Head, 12/14 taper, 32 mm diameter, neck length +3.5 mm, sterile, Zimmer, Warsaw, IN; REF 00-6418-032-03 and 00-6428-032-03.
The Alumina Ceramic Femoral Heads are modula Terminated |
LZO | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.