K103816 is an FDA 510(k) clearance for the COHESION BONE CEMENT. This device is classified as a Cement, Bone, Vertebroplasty (Class II - Special Controls, product code NDN).
Submitted by Teknimed Sas (Round Rock, US). The FDA issued a Cleared decision on February 4, 2011, 37 days after receiving the submission on December 29, 2010.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3027.
| 510(k) Number | K103816 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 29, 2010 |
| Decision Date | February 04, 2011 |
| Days to Decision | 37 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 |