K131810 is an FDA 510(k) clearance for the OSSEUS BLACK DIAMOND PEDICLE SCREW SYSTEM. This device is classified as a Orthosis, Spondylolisthesis Spinal Fixation (Class II - Special Controls, product code MNH).
Submitted by Osseus Fusion Systems, LLC (Round Rock, US). The FDA issued a Cleared decision on August 8, 2013, 50 days after receiving the submission on June 19, 2013.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3070.
| 510(k) Number | K131810 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 19, 2013 |
| Decision Date | August 08, 2013 |
| Days to Decision | 50 days |
| Submission Type | Traditional |
| Review Panel | Orthopedic (OR) |
| Summary | Summary PDF |
| Product Code | MNH - Orthosis, Spondylolisthesis Spinal Fixation |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 888.3070 |