510(k) K971358 ยท MAI Fastener, Fixation, Biodegradable, Soft Tissue
BIO-INTERFERENCE SCREW, 7 MM, 8 MM, 9 MM
| Applicant | Arthrex, Inc., Washington DC, US |
| Decision | Substantially Equivalent, Jul 9, 1997 |
| Received | Apr 11, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K971358
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.