510(k) K162732 · MEH Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate
Exactech® Alteon® HA Femoral Stem
| Applicant | Exactech, Inc., Gainesville FL, US |
| Decision | Substantially Equivalent, Apr 26, 2017 |
| Received | Sep 29, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K162732
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 18, 2018 | Exactech, Inc. Alteon HA Femoral Stem, Press-Fit, Extended Offset, Cementless, HA Coated, Collared, Size 5
All Exactech Hip Systems are indicated for use in skeletally mature individuals undergoing primary surgery Terminated |
MEH | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.