K081297 is an FDA 510(k) clearance for the VERTEX RECONSTRUCTION SYSTEM. This device is classified as a Appliance, Fixation, Spinal Interlaminal (Class II - Special Controls, product code KWP).
Submitted by Medtronic Sofamor Danek (Memphis, US). The FDA issued a Cleared decision on June 11, 2008, 35 days after receiving the submission on May 7, 2008.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3050.
| 510(k) Number | K081297 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 07, 2008 |
| Decision Date | June 11, 2008 |
| Days to Decision | 35 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 |