510(k) K190904 ยท LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
Conformis BeneFIT Hip System
| Applicant | Conformis, Inc., Billerica MA, US |
| Decision | Substantially Equivalent, Aug 28, 2019 |
| Received | Apr 8, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K190904
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 16, 2023 | Conformis, Inc. CONFORMIS HIP-SCREW-6.5MM X 25MM, STERILE EO Open, Classified |
OQG | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.