510(k) K981193 ยท MBI Fastener, Fixation, Nondegradable, Soft Tissue
INNOVASIVE 3.5MM METAL ROC XS SUTURE BONE FASTENER
| Applicant | Innovasive Devices, Inc., Marlboro MA, US |
| Decision | Substantially Equivalent, Jun 16, 1998 |
| Received | Apr 2, 1998 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K981193
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.