510(k) K192198 ยท LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
Conformis Hip System
| Applicant | Conformis, Inc., Billerica MA, US |
| Decision | Substantially Equivalent, Nov 6, 2019 |
| Received | Aug 13, 2019 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K192198
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 21, 2020 | Conformis, Inc. iTotal Hip Replacement System, Model number HAA-050-D020-020102
The Conformis Hip System includes standard hip replacement components as well as the following patient specific components: femoral ste Terminated |
LPH | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.