510(k) K221104 · MEH Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate
Actera hip system
| Applicant | Conformis, Inc., Billerica MA, US |
| Decision | Substantially Equivalent, Aug 4, 2022 |
| Received | Apr 14, 2022 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K221104
| 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.