510(k) K963100 ยท LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
TRONZO ACETABULAR FIXATION COMPONENT (1 99-02-00XX (ACE. FIXATION CUP) XX=OD OF ACE. CUP
| Applicant | Endotec, Inc., South Orange NJ, US |
| Decision | Substantially Equivalent, Feb 12, 1997 |
| Received | Aug 9, 1996 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K963100
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.