510(k) K202484 ยท LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
Cordera Hip System
| Applicant | Conformis, Inc., Billerica MA, US |
| Decision | Substantially Equivalent, Sep 24, 2020 |
| Received | Aug 31, 2020 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K202484
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 15, 2025 | Conformis Inc. restor3d Cordera Hip System. ACETABULAR LINER GRP C 36MM LIP. Model Number: HDL-060-C22L-000101
Acetabular Liner for Cordera Hip System Open, Classified |
LPH | None listed |
| 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.