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 |