510(k) K161155 ยท MEH Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate
Origin Coxa Vara Hip Stem
| Applicant | Signature Orthopaedics Pty, Ltd., Lane Cove West, AU |
| Decision | Substantially Equivalent, Jul 19, 2016 |
| Received | Apr 25, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K161155
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 9, 2019 | Signature Orthopaedics Europe Ltd Encina HA Femoral Stem, Size 11 Coxa Vara Collared, REF 100-30-011, Ti6AI4V Allow with HA Coating, For use with Stinson Orthopedics Inc. Total Hip Replacement System Only, CEMENTLESS, UDI: (01) 008411 Open, Classified |
MEH | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.