510(k) K112097 ยท MRW System, Facet Screw Spinal Device
GIBRALT SPINE SYSTEMS FACET SCREW 04.0,04.5
| Applicant | Exactech, Inc., Gainesville FL, US |
| Decision | Substantially Equivalent, Nov 21, 2011 |
| Received | Jul 22, 2011 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K112097
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.