510(k) K122170 ยท HSB Rod, Fixation, Intramedullary And Accessories
SMITH & NEPHEW, INC. INTRAMEDULLARY NAIL SYSTEM INSTRUMENTATION
| Applicant | Smith & Nephew, Inc., Cordova TN, US |
| Decision | Substantially Equivalent, Oct 19, 2012 |
| Received | Jul 23, 2012 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K122170
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 7, 2019 | Smith & Nephew, Inc. LAG SCREW 3.2MM GUIDE PIN SLEEVE, REF 71674032 - Product Usage: The TRIGEN InterTAN nails are indicated for fractures of the femur including: simple shaft fractures, comminuted shaft fractures, spiral Terminated |
LXH | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.