510(k) K971922 ยท MBI Fastener, Fixation, Nondegradable, Soft Tissue
INNOVASIVE 2.8MM AND 3.5MM ROC EZ SUTURE BONE FASTENER
| Applicant | Innovasive Devices, Inc., Marlboro MA, US |
| Decision | Substantially Equivalent, Aug 7, 1997 |
| Received | May 23, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K971922
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.