510(k) K043547 ยท KWA Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component)
COMPRESS SEGMENTAL FEMORAL REPLACEMENT SYSTEM
| Applicant | Biomet, Inc., Warsaw IN, US |
| Decision | Substantially Equivalent, Aug 5, 2005 |
| Received | Dec 23, 2004 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K043547
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 29, 2009 | Biomet, Inc. Biomet OSS FINN Proximal Femoral Trial 7 cm resection/right, stainless steel, Biomet Orthopedics, Inc., Warsaw, IN; REF 32-472086.
A non-powered, orthopedic manual surgical instrument for use with ot Terminated |
KRO | None listed |
| Jun 29, 2009 | Biomet, Inc. Biomet OSS FINN Proximal Femoral Trial 7 cm resection/left, stainless steel, Biomet Orthopedics, Inc., Warsaw, IN; REF 32-472087.
A non-powered, orthopedic manual surgical instrument for use with oth Terminated |
KRO | None listed |
| Jun 29, 2009 | Biomet, Inc. Biomet OSS Letson Proximal Femoral Trial 7 cm resection/right, stainless steel, Biomet Orthopedics, Inc., Warsaw, IN; REF 32-472088.
A non-powered, orthopedic manual surgical instrument for use with Terminated |
KRO | None listed |
| Jun 29, 2009 | Biomet, Inc. Biomet OSS Letson Proximal Femoral Trial 7 cm resection/left, stainless steel, Biomet Orthopedics, Inc., Warsaw, IN; REF 32-472089.
A non-powered, orthopedic manual surgical instrument for use with o Terminated |
KRO | None listed |
| Jun 29, 2009 | Biomet, Inc. Biomet OSS Elliptical Proximal Femoral Trial 7 cm, right provisional, stainless steel, Biomet Orthopedics, Inc., Warsaw, IN; REF 32-472124.
A non-powered, orthopedic manual surgical instrument for us Terminated |
KRO | None listed |
| Jun 29, 2009 | Biomet, Inc. Biomet OSS Elliptical Proximal Femoral Trial 7 cm left provisional, stainless steel, Biomet Orthopedics, Inc., Warsaw, IN; REF 32-472125.
A non-powered, orthopedic manual surgical instrument for use Terminated |
KRO | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.