The following data is part of a premarket notification filed by Biomet Microfixation with the FDA for Facial Prebent Plating With Virtual Surgical Planning.
| Device ID | K132600 |
| 510k Number | K132600 |
| Device Name: | FACIAL PREBENT PLATING WITH VIRTUAL SURGICAL PLANNING |
| Classification | Plate, Bone |
| Applicant | BIOMET MICROFIXATION 1520 TRADEPORT DR. Jacksonville, FL 32218 |
| Contact | Elizabeth Wheeler |
| Correspondent | Elizabeth Wheeler BIOMET MICROFIXATION 1520 TRADEPORT DR. Jacksonville, FL 32218 |
| Product Code | JEY |
| Subsequent Product Code | DZJ |
| Subsequent Product Code | LLZ |
| CFR Regulation Number | 872.4760 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-08-20 |
| Decision Date | 2013-10-02 |
| Summary: | summary |