K063248 is an FDA 510(k) clearance for the ARCUATE VERTEBRAL AUGMENTATION SYSTEM. This device is classified as a Cement, Bone, Vertebroplasty (Class II - Special Controls, product code NDN).
Submitted by Medtronic Sofamor Danek (Memphis, US). The FDA issued a Cleared decision on March 13, 2007, 138 days after receiving the submission on October 26, 2006.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3027.
| 510(k) Number | K063248 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 26, 2006 |
| Decision Date | March 13, 2007 |
| Days to Decision | 138 days |
| Submission Type | Traditional |
| Review Panel | Orthopedic (OR) |
| Summary | Summary PDF |
| Product Code | NDN — Cement, Bone, Vertebroplasty |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 888.3027 |