510(k) K030972 ยท KWL Prosthesis, Hip, Hemi-, Femoral, Metal
FIXION UNIPOLAR MODULAR HEMI-HIP SYSTEM (FIXION MH)
| Applicant | Disc-O-Tech Medical Technologies, Ltd., Herzelia, IL |
| Decision | Substantially Equivalent, May 30, 2003 |
| Received | Mar 28, 2003 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K030972
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.