510(k) K162078 ยท HRS Plate, Fixation, Bone
EVOS Small Fragment Plating System
| Applicant | Smith & Nephew, Inc., Memphis TN, US |
| Decision | Substantially Equivalent, Nov 18, 2016 |
| Received | Jul 27, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K162078
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 25, 2021 | Smith & Nephew, Inc. Smith and Nephew EVOS Self-Tapping Locking Screw SST: (1)REF 72413575, 3.5MM x 75MM, and (2) REF 72413570, 3.5MM X 70MM. Sterile. Open, Classified |
HRS | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.