510(k) K014226 ยท KWL Prosthesis, Hip, Hemi-, Femoral, Metal
UNITRAX MODULAR UNIPOLAR SYSTEM
| Applicant | Howmedica Osteonics Corp., Allendale NJ, US |
| Decision | Substantially Equivalent, Jan 25, 2002 |
| Received | Dec 26, 2001 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K014226
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 16, 2024 | Howmedica Osteonics Corp. UNITRAX Endoprosthesis Head Component - 43mm. Implantable component used in partial hip arthroplasty.
Catalog Number: 6942-5-043 Open, Classified |
KWL | None listed |
| Jul 16, 2024 | Howmedica Osteonics Corp. UNITRAX Endoprosthesis Head Component - 42mm. Implantable component used in partial hip arthroplasty.
Catalog Number: 6942-5-042 Open, Classified |
KWL | None listed |
| Jul 16, 2024 | Howmedica Osteonics Corp. UNITRAX Endoprosthesis Head Component - 38mm. Implantable component used in partial hip arthroplasty.
Catalog Number: 6942-5-038 Open, Classified |
KWL | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.