K102488 is an FDA 510(k) clearance for the APEX SPINE SYSTEM W/ COCR RODS. This device is classified as a Orthosis, Spondylolisthesis Spinal Fixation (Class II - Special Controls, product code MNH).
Submitted by Spinecraft, LLC (Westchester, US). The FDA issued a Cleared decision on December 10, 2010, 101 days after receiving the submission on August 31, 2010.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3070.
| 510(k) Number | K102488 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 31, 2010 |
| Decision Date | December 10, 2010 |
| Days to Decision | 101 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 |