510(k) K970292 ยท MBI Fastener, Fixation, Nondegradable, Soft Tissue
IN-FAST BONE SCREW SYSTEM/IN-FAST BONE SCREW INSERTER/IN-FAST BONE SCREW
| Applicant | Influence, Inc., San Francisco CA, US |
| Decision | Substantially Equivalent, Apr 23, 1997 |
| Received | Jan 24, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K970292
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 16, 2008 | American Medical Systems AMS In-Fast Ultra Kit with Polypropylene Suture, REF 72403885. Sterile Transvaginal Bladder Neck Support System. Terminated |
MBI | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.