K121589 is an FDA 510(k) clearance for the BIOMET MICROFIXATION FACIAL PLATING SYSTEM. This device is classified as a Plate, Bone (Class II - Special Controls, product code JEY).
Submitted by Biomet Microfixation (Jacksonville, US). The FDA issued a Cleared decision on September 21, 2012, 113 days after receiving the submission on May 31, 2012.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.4760.
| 510(k) Number | K121589 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 31, 2012 |
| Decision Date | September 21, 2012 |
| Days to Decision | 113 days |
| Submission Type | Special |
| Review Panel | Dental (DE) |
| Summary | Summary PDF |
| Product Code | JEY — Plate, Bone |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 872.4760 |