K080108 is an FDA 510(k) clearance for the CORTOSS BONE AUGMENTATION MATERIAL. This device is classified as a Cement, Bone, Vertebroplasty (Class II - Special Controls, product code NDN).
Submitted by Orthovita, Inc. (Malver, US). The FDA issued a Cleared decision on June 5, 2009, 507 days after receiving the submission on January 15, 2008.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3027.
| 510(k) Number | K080108 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 15, 2008 |
| Decision Date | June 05, 2009 |
| Days to Decision | 507 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 |