510(k) K201346 ยท HSB Rod, Fixation, Intramedullary And Accessories
DePuy Synthes Retrograde Femoral Nail Advanced System, DePuy Synthes Locking Screws for Medullary Nails, 5.0 mm
| Applicant | Synthes (USA) Products, LLC, West Chester PA, US |
| Decision | Substantially Equivalent, Sep 23, 2020 |
| Received | May 21, 2020 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K201346
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 21, 2025 | Synthes (USA) Products LLC LOW PROF LCKNG SCREW, F/IM NAIL 5.0MM / L, 46MM / XL25/ STER. Product Code: 04.045.346TS.
Used in RFN-ADVANCEDTM Retrograde Femoral Nailing (RFNA) System and the Tibial Nail
Advanced System. Open, Classified |
JDS | None listed |
| Oct 21, 2025 | Synthes (USA) Products LLC LOW PROF LCKNG SCREW, F/IM NAIL 5.0MM / L, 42MM / XL25/ STER. Product Code: 04.045.342TS.
Used in RFN-ADVANCEDTM Retrograde Femoral Nailing (RFNA) System and the Tibial Nail
Advanced System. Open, Classified |
JDS | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.