510(k) K212815 · LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
My3D® Personalized Pelvic Reconstruction
| Applicant | Onkos Surgical, Parsippany NJ, US |
| Decision | Substantially Equivalent, Jul 6, 2022 |
| Received | Sep 3, 2021 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K212815
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 6, 2026 | Onkos Surgical, Inc. Onkos Surgical Inc. My3D Personalized Pelvic Implant, Porous, Left
REF PV-ACREC-04M Open, Classified |
LPH | None listed |
| Oct 6, 2026 | Onkos Surgical, Inc. Onkos Surgical Inc. My3D Personalized Pelvic Implant, Porous, Left
REF PV-ACREC-04M Open, Classified |
LPH | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.