K110926 is an FDA 510(k) clearance for the BONE PLATE. This device is classified as a Plate, Bone (Class II - Special Controls, product code JEY).
Submitted by Biomaterials Korea, Inc. (Greenwood Village, US). The FDA issued a Cleared decision on December 8, 2011, 251 days after receiving the submission on April 1, 2011.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.4760.
| 510(k) Number | K110926 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 01, 2011 |
| Decision Date | December 08, 2011 |
| Days to Decision | 251 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | Statement |
| Product Code | JEY - Plate, Bone |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 872.4760 |