K063453 is an FDA 510(k) clearance for the VERTEFIX PEDICLE SCREW SPINAL SYSTEM. This device is classified as a Orthosis, Spinal Pedicle Fixation (Class II - Special Controls, product code MNI).
Submitted by Elite Surgical Supplies (Pty), Ltd. (Marietta, US). The FDA issued a Cleared decision on August 30, 2007, 288 days after receiving the submission on November 15, 2006.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3070.
| 510(k) Number | K063453 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 15, 2006 |
| Decision Date | August 30, 2007 |
| Days to Decision | 288 days |
| Submission Type | Traditional |
| Review Panel | Orthopedic (OR) |
| Summary | Summary PDF |
| Product Code | MNI - Orthosis, Spinal Pedicle Fixation |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 888.3070 |