510(k) K000080 ยท HWC Screw, Fixation, Bone
ASNIS III CANNULATED SCREW SYSTEM
| Applicant | Howmedica Osteonics Corp., Allendale NJ, US |
| Decision | Substantially Equivalent, Apr 3, 2000 |
| Received | Jan 11, 2000 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K000080
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 27, 2013 | Stryker Howmedica Osteonics Corp. Stryker
1) Asnis III Cannulated Screw REF 604640
4.0x40mm TL 13.5mm
2) Asnis III Cannulated Screw REF 604642S
4.0x42mm TL 14mm, sterile
Product Usage: The Asnis III Cannulated Screw System is inte Terminated |
HWC | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.