510(k) K972326 ยท MBI Fastener, Fixation, Nondegradable, Soft Tissue
PEBA ANCHOR/SUTURE COMBINATION
| Applicant | Orthopaedic Biosystems, Ltd., Scotsdale AZ, US |
| Decision | Substantially Equivalent, Feb 6, 1998 |
| Received | Jun 23, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K972326
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 30, 2019 | Smith & Nephew, Inc. TwinFix Ti 2.8 mm HS Suture Anchor - Product Usage: A fixation device intended to provide secure attachment of soft tissue to bone. Terminated |
MBI | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.