510(k) K153649 · MEH Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate
Exactech® Novation® Element Press-fit Femoral Stem
| Applicant | Exactech, Inc., Gainesville FL, US |
| Decision | Substantially Equivalent, Aug 31, 2016 |
| Received | Dec 21, 2015 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K153649
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.