K063464 is an FDA 510(k) clearance for the ATLAS SPINE VERTEBRAL BODY REPLACEMENT. This device is classified as a Spinal Vertebral Body Replacement Device (Class II - Special Controls, product code MQP).
Submitted by Atlas Spine, Inc. (Jupiter, US). The FDA issued a Cleared decision on March 9, 2007, 113 days after receiving the submission on November 16, 2006.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3060.
| 510(k) Number | K063464 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 16, 2006 |
| Decision Date | March 09, 2007 |
| Days to Decision | 113 days |
| Submission Type | Traditional |
| Review Panel | Orthopedic (OR) |
| Summary | Summary PDF |
| Product Code | MQP - Spinal Vertebral Body Replacement Device |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 888.3060 |