510(k) K080358 ยท HWC Screw, Fixation, Bone
PLLA, HA SCREW
| Applicant | Smith & Nephew Inc., Endoscopy Div., Andover MA, US |
| Decision | Substantially Equivalent, Apr 23, 2008 |
| Received | Feb 11, 2008 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K080358
| 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 |
| Mar 19, 2012 | Smith & Nephew, Inc. Endoscopy Division Smith & Nephew BIOSURE HA Interference Screw, 7 mm x 25 mm
Catalog Number: 72201772.
The BIOSURE HA Interference Screw is indicated for fixation of bone-tendon-bone or soft tissue grafts during anter Terminated |
HWC | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.