510(k) K191002 ยท LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
OR3O Dual Mobility System
| Applicant | Smith & Nephew, Inc., Cordova TN, US |
| Decision | Substantially Equivalent, Oct 31, 2019 |
| Received | Apr 16, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K191002
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.