510(k) K071420 ยท MRW System, Facet Screw Spinal Device
CHAMELEON FIXATION SYSTEM
| Applicant | Spinefrontier, Inc., Beverly MA, US |
| Decision | Substantially Equivalent, Jan 16, 2008 |
| Received | May 22, 2007 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K071420
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 2, 2013 | SpineFrontier, Inc. Drill Guide - Chameleon FacetFuse Fixation System, Model: 11-00028 Rev. A
FacetFuse Drill Guides were designed to provide a concentric pathway for the drills and taps to access the bone while protect Terminated |
FZX | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.