The following data is part of a premarket notification filed by Biomet Microfixation with the FDA for Biomet Microfixation Facial Plating System.
| Device ID | K121589 | 
| 510k Number | K121589 | 
| Device Name: | BIOMET MICROFIXATION FACIAL PLATING SYSTEM | 
| Classification | Plate, Bone | 
| Applicant | BIOMET MICROFIXATION 1520 TRADEPORT DR. Jacksonville, FL 32218 | 
| Contact | Lauren Jasper | 
| Correspondent | Lauren Jasper BIOMET MICROFIXATION 1520 TRADEPORT DR. Jacksonville, FL 32218 | 
| Product Code | JEY | 
| CFR Regulation Number | 872.4760 [🔎] | 
| Decision | Substantially Equivalent (SESE) | 
| Type | Special | 
| 3rd Party Reviewed | No | 
| Combination Product | No | 
| Date Received | 2012-05-31 | 
| Decision Date | 2012-09-21 | 
| Summary: | summary |