510(k) K193214 ยท MBI Fastener, Fixation, Nondegradable, Soft Tissue
WasherLoc and No-Profile Screw and Washer Systems, Biomet Cannulated Screw System, Biomet Headless Compression and Twist-Off Screws
| Applicant | Biomet, Inc., Warsaw IN, US |
| Decision | Substantially Equivalent, Nov 10, 2020 |
| Received | Nov 21, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K193214
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.