510(k) K132126 ยท MRW System, Facet Screw Spinal Device
SPECTRUM SPINE FENESTRATED FACET SCREW SYSTEM
| Applicant | Spectrum Spine, LLC, Waxhaw NC, US |
| Decision | Substantially Equivalent, Oct 28, 2013 |
| Received | Jul 10, 2013 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K132126
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.