510(k) K243768 · MBH Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer
iTotal® Identity Cruciate Retaining 3DP Porous Knee Replacement System
| Applicant | Restor3D, Inc., Durham NC, US |
| Decision | Substantially Equivalent, Mar 27, 2025 |
| Received | Dec 6, 2024 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K243768
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.