510(k) K963396 ยท MAI Fastener, Fixation, Biodegradable, Soft Tissue
BIOSPHERE SUTURE ANCHOR
| Applicant | Instrument Makar, Inc., Lansing MI, US |
| Decision | Substantially Equivalent, May 6, 1997 |
| Received | Aug 28, 1996 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K963396
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.