The following data is part of a premarket notification filed by Biomet Microfixation with the FDA for Biomet Microfixation Omnimax Mmf System.
| Device ID | K202969 |
| 510k Number | K202969 |
| 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 | 2020-09-30 |
| Decision Date | 2021-08-05 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00841036274719 | K202969 | 000 |
| 00841036274702 | K202969 | 000 |
| 00841036274689 | K202969 | 000 |