510(k) K192071 ยท LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
iNSitu Total Hip System
| Applicant | Theken Companies, LLC, Akron OH, US |
| Decision | Substantially Equivalent, Aug 30, 2019 |
| Received | Aug 2, 2019 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K192071
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.