K110353 is an FDA 510(k) clearance for the MOUNTAINEER OCT SPINAL SYSTEM. This device is classified as a Appliance, Fixation, Spinal Interlaminal (Class II - Special Controls, product code KWP).
Submitted by Depuy Spine, Inc. (Raynham, US). The FDA issued a Cleared decision on April 7, 2011, 59 days after receiving the submission on February 7, 2011.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3050.
| 510(k) Number | K110353 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 07, 2011 |
| Decision Date | April 07, 2011 |
| Days to Decision | 59 days |
| Submission Type | Special |
| Review Panel | Orthopedic (OR) |
| Summary | Summary PDF |
| Product Code | KWP - Appliance, Fixation, Spinal Interlaminal |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 888.3050 |