K000094 is an FDA 510(k) clearance for the MODIFICATION TO CD HORIZON SPINAL SYSTEM. This device is classified as a Orthosis, Spondylolisthesis Spinal Fixation (Class II - Special Controls, product code MNH).
Submitted by Medtronic Sofamor Danek USA, Inc. (Memphis, US). The FDA issued a Cleared decision on February 8, 2000, 26 days after receiving the submission on January 13, 2000.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3070.
| 510(k) Number | K000094 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 13, 2000 |
| Decision Date | February 08, 2000 |
| Days to Decision | 26 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 |