510(k) K150862 ยท MEH Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate
DePuy Actis Duofox Hip Prosthesis
| Applicant | DePuy Orthopaedics, Inc., Warsaw IN, US |
| Decision | Substantially Equivalent, Sep 25, 2015 |
| Received | Apr 1, 2015 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K150862
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 21, 2016 | Depuy Orthopaedics Inc. ACTIS Flex Reamers SZ 0/1; 2/3; 4/5; 6/7; 8/9; 10/11; 12, Product is sold non-sterile, these instruments are packed non-sterile, within a rigid tube with foam protectors, with label and IFU Terminated |
MEH | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.