510(k) K011007 ยท MBI Fastener, Fixation, Nondegradable, Soft Tissue
TENODESIS SCREW, 5.5 MM, MODEL AR-1350-55
| Applicant | Arthrex, Inc., Naples FL, US |
| Decision | Substantially Equivalent, Jun 12, 2001 |
| Received | Apr 4, 2001 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K011007
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.