K062452 is an FDA 510(k) clearance for the KIT MENDEC SPINE AND DELIVERY SYSTEM. This device is classified as a Cement, Bone, Vertebroplasty (Class II - Special Controls, product code NDN).
Submitted by Tecres S.P.A. (Rockville, US). The FDA issued a Cleared decision on September 21, 2006, 30 days after receiving the submission on August 22, 2006.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3027.
| 510(k) Number | K062452 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 22, 2006 |
| Decision Date | September 21, 2006 |
| Days to Decision | 30 days |
| Submission Type | Special |
| 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 |