510(k) K193398 ยท MEH Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate
Summit DuoFix HA Coating
| Applicant | DePuy Orthopaedics, Inc., Warsaw IN, US |
| Decision | Substantially Equivalent, Feb 4, 2020 |
| Received | Dec 6, 2019 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K193398
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.