510(k) K080980 ยท MEH Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate
EXACTECH NOVATION ELEMENT PRESS-FIT FEMORAL STEMS
| Applicant | Exactech, Inc., Gainesville FL, US |
| Decision | Substantially Equivalent, May 6, 2008 |
| Received | Apr 7, 2008 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K080980
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 2, 2015 | Exactech, Inc. Novation Element Press-Fit, Cementless, HA Coated, Collared, Standard Offset, Size 9, Femoral Hip Implant Stems, Intended for press-fit fixation Terminated |
MEH | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.