K101762 is an FDA 510(k) clearance for the VIPER F2 FACET FIXATION SYSTEM. This device is classified as a System, Facet Screw Spinal Device.
Submitted by Depuy Spine, Inc. (Raynham, US). The FDA issued a Cleared decision on November 15, 2010, 146 days after receiving the submission on June 22, 2010.
This device falls under the Orthopedic FDA review panel.
| 510(k) Number | K101762 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 22, 2010 |
| Decision Date | November 15, 2010 |
| Days to Decision | 146 days |
| Submission Type | Special |
| Review Panel | Orthopedic (OR) |
| Summary | Summary PDF |
| Product Code | MRW - System, Facet Screw Spinal Device |
| Device Class | - |