510(k) K142948 ยท MAI Fastener, Fixation, Biodegradable, Soft Tissue
BIOSURE REGENESORB interference Screw
| Applicant | Smith & Nephew, Inc., Andover MA, US |
| Decision | Substantially Equivalent, Jan 13, 2015 |
| Received | Oct 10, 2014 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K142948
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 18, 2025 | Smith & Nephew, Inc. BIOSURE HA SCREW, 6MM x 20 MM. Threaded metallic bone fixation fastener. Open, Classified |
HWC | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.