The following data is part of a premarket notification filed by Biomet Microfixation with the FDA for Biomet Microfixation Omnimax Mmf System.
| Device ID | K152326 |
| 510k Number | K152326 |
| Device Name: | Biomet Microfixation OmniMax MMF System |
| Classification | Plate, Bone |
| Applicant | BIOMET MICROFIXATION 1520 TRADEPORT DRIVE Jacksonville, FL 32218 |
| Contact | Lauren Jasper |
| Correspondent | Lauren Jasper BIOMET MICROFIXATION 1520 TRADEPORT DRIVE Jacksonville, FL 32218 |
| Product Code | JEY |
| CFR Regulation Number | 872.4760 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-08-18 |
| Decision Date | 2015-12-10 |
| Summary: | summary |