510(k) K100154 ยท MRW System, Facet Screw Spinal Device
FIXCET SPINAL FACET SCREW SYSTEM
| Applicant | X-Spine Systems, Inc., Miamisburg OH, US |
| Decision | Substantially Equivalent, May 21, 2010 |
| Received | Jan 20, 2010 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K100154
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.