K110197 is an FDA 510(k) clearance for the EXACTECH GIBRALT SPINAL SYSTEM. This device is classified as a Orthosis, Spinal Pedicle Fixation (Class II - Special Controls, product code MNI).
Submitted by Exactech, Inc. (Gainesville, US). The FDA issued a Cleared decision on July 15, 2011, 172 days after receiving the submission on January 24, 2011.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3070.
| 510(k) Number | K110197 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 24, 2011 |
| Decision Date | July 15, 2011 |
| Days to Decision | 172 days |
| Submission Type | Traditional |
| Review Panel | Orthopedic (OR) |
| Summary | Summary PDF |
| Product Code | MNI — Orthosis, Spinal Pedicle Fixation |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 888.3070 |