510(k) K954338 ยท MBI Fastener, Fixation, Nondegradable, Soft Tissue
INNOVASIVE 1.9MM ROC SUTURE BONE FASTENER
| Applicant | Innovasive Devices, Inc., Hopkinton MA, US |
| Decision | Substantially Equivalent for Some Indications, Mar 21, 1996 |
| Received | Sep 18, 1995 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K954338
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.