510(k) K121636 ยท LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
ZENITH, FEMORAL STEM ZENITH, DISTAL CENTRALIZER FOMORAL HEAD ACETABULAR INSERT
| Applicant | Tgm Medical, Inc., El Dorado Hills CA, US |
| Decision | Substantially Equivalent, Oct 24, 2012 |
| Received | Jun 4, 2012 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K121636
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.