K062666 is an FDA 510(k) clearance for the VUSION TS, PS, AND CS PARTIAL VERTEBRAL BODY REPLACEMENTS. This device is classified as a Spinal Vertebral Body Replacement Device (Class II - Special Controls, product code MQP).
Submitted by Ortho Development Corp. (Draper, US). The FDA issued a Cleared decision on January 25, 2007, 140 days after receiving the submission on September 7, 2006.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3060.
| 510(k) Number | K062666 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 07, 2006 |
| Decision Date | January 25, 2007 |
| Days to Decision | 140 days |
| Submission Type | Traditional |
| Review Panel | Orthopedic (OR) |
| Summary | Statement |
| Product Code | MQP — Spinal Vertebral Body Replacement Device |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 888.3060 |