510(k) K945670 ยท JDW Pin, Fixation, Threaded
KIRSCHNER (K-WIRE), STEINMAN PINS
| Applicant | Brasseler USA I, L.P., Savannah GA, US |
| Decision | Substantially Equivalent, Mar 7, 1995 |
| Received | Nov 18, 1994 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K945670
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 28, 2022 | Brasseler USA, Medical L.L.C. Brasseler USA, K-WIRE, Double Trocar Smooth, REF KM172-26-35S Terminated |
HTY | None listed |
| Dec 11, 2019 | Brasseler USA I Lp Brasseler USA KM169-39-76 Steinmann Pin Single Diamond Smooth, Diameter 2.8 mm, Length 228 mm
Product Usage: A Steinmann Pin is used for internal fixation of large bone fractures. Terminated |
HTY | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.