510(k) K113320 ยท MEH Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate
NOVATION ELEMENT FEMORAL STEM, 12/14 COLLARLESS STANDARD/HIGH OFFSET HA COATED PRESS-FIT, SZ 8-12
| Applicant | Exactech, Inc., Gainesville FL, US |
| Decision | Substantially Equivalent, Mar 16, 2012 |
| Received | Nov 10, 2011 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K113320
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.