510(k) K232267 ยท HSB Rod, Fixation, Intramedullary And Accessories
Precice Max System
| Applicant | Nuvasive Specialized Orthopedics, Incorporated, Alisa Viejo CA, US |
| Decision | Substantially Equivalent, Dec 15, 2023 |
| Received | Jul 31, 2023 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K232267
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 21, 2024 | NuVasive Specialized Orthopedics, Inc. Precice Max REF:
PM10.0-80B265 PRECICE MAX Antegrade Femur Piriformis Straight 10.0mm x 265mm
PM10.0-80B280 PRECICE MAX Antegrade Femur Piriformis Straight 10.0mm x 280mm
PM10.0-80B305 PRECICE MA Open, Classified |
HSB | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.