K080828 is an FDA 510(k) clearance for the MOUNTAINEER OCT SPINAL SYSTEM. This device is classified as a Orthosis, Spondylolisthesis Spinal Fixation (Class II - Special Controls, product code MNH).
Submitted by Depuy Spine, Inc. (Raynham, US). The FDA issued a Cleared decision on June 27, 2008, 94 days after receiving the submission on March 25, 2008.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3070.
| 510(k) Number | K080828 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 25, 2008 |
| Decision Date | June 27, 2008 |
| Days to Decision | 94 days |
| Submission Type | Special |
| 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 |