510(k) K222971 ยท MBI Fastener, Fixation, Nondegradable, Soft Tissue
ULTRABUTTON QUAD Adjustable Fixation Device; ULTRABUTTON BB Adjustable Fixation Device; ULTRABUTTON TIB SMALL Adjustable Fixation Device; ULTRABUTTON TIB MEDIUM Adjustable Fixation Device; ULTRABUTTON TIB LARGE Adjustable Fixation Device
| Applicant | Smith & Nephew, Inc., Andover MA, US |
| Decision | Substantially Equivalent, Feb 17, 2023 |
| Received | Sep 27, 2022 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K222971
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.