510(k) K052576 ยท HWC Screw, Fixation, Bone
SBI AUTOFIX
| Applicant | Small Bone Innovations, LLC, New York NY, US |
| Decision | Substantially Equivalent, Nov 7, 2005 |
| Received | Sep 19, 2005 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K052576
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 30, 2014 | Small Bone Innovations Small Bone Innovations 3.0/4.0mm AutoFIX" Cannulated Compression Screw System Sets, Implants, and Instruments
Indications for Use: AutoFIX" cannu lated screws are indicated for the treatment of fr Terminated |
HWC | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.