510(k) K161184 ยท LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
iNSitu Total Hip System
| Applicant | Theken Companies, LLC, Akron OH, US |
| Decision | Substantially Equivalent, Oct 14, 2016 |
| Received | Apr 27, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K161184
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.