510(k) K120493 ยท HWC Screw, Fixation, Bone
MINI CANNULATED HEADED AND HEADLESS SCREW SET
| Applicant | Instratek, Inc., Houston TX, US |
| Decision | Substantially Equivalent, May 17, 2012 |
| Received | Feb 17, 2012 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K120493
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 22, 2014 | Instratek, Incorporated Mini Cannulated Titanium Headed and Headless Screw Set and 2.5, 3.0, and 4.0 mm countersink/depth gauges in the Mini Screw Set/System Terminated |
HWC | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.