510(k) K101700 ยท HWC Screw, Fixation, Bone
IO FIX HAND, IO FIX FOOT, EXTREMITY MEDICAL SCREW SYSTEM
| Applicant | Extremity Medical, LLC, Parsippany NJ, US |
| Decision | Substantially Equivalent, Oct 12, 2010 |
| Received | Jun 17, 2010 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K101700
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 30, 2013 | Extremity Medical LLC Extremity Medical, IO FiX System Accessory. Catalog Number 101-00010.
This screw measuring device is an accessory to the IO FiX Screw and Washer System that is used to measure the length of the sc Terminated |
HWC | None listed |
| Nov 18, 2012 | Extremity Medical LLC IO Fix IntraOsseous Fixation System; Extremity Medical. www.extremitymedical.com; Customer Service: 888.499.0079.
The Extremity Medical Screw and Washer System is intended for reduction and internal Terminated |
HWC | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.