K112097 is an FDA 510(k) clearance for the GIBRALT SPINE SYSTEMS FACET SCREW 04.0,04.5. This device is classified as a System, Facet Screw Spinal Device.
Submitted by Exactech, Inc. (Gainesville, US). The FDA issued a Cleared decision on November 21, 2011, 122 days after receiving the submission on July 22, 2011.
This device falls under the Orthopedic FDA review panel.
| 510(k) Number | K112097 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 22, 2011 |
| Decision Date | November 21, 2011 |
| Days to Decision | 122 days |
| Submission Type | Traditional |
| Review Panel | Orthopedic (OR) |
| Summary | Summary PDF |
| Product Code | MRW — System, Facet Screw Spinal Device |
| Device Class | — |