510(k) K110197 ยท MNI Orthosis, Spinal Pedicle Fixation
EXACTECH GIBRALT SPINAL SYSTEM
| Applicant | Exactech, Inc., Gainesville FL, US |
| Decision | Substantially Equivalent, Jul 15, 2011 |
| Received | Jan 24, 2011 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K110197
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 18, 2014 | Exactech, Inc. Gibralt Spine System Polyaxial Screw
Intended to promote fusion of the cervical spine, and the thoracic spine, (C3-T3), the Gibralt Spinal System is indicated for the following: DDD (neck pain of dis Terminated |
MNI | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.