The following data is part of a premarket notification filed by Biomet Microfixation with the FDA for Biomet Microfixation Omnimax Mmf System.
| Device ID | K143336 |
| 510k Number | K143336 |
| 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 | 2014-11-20 |
| Decision Date | 2015-04-01 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00841036275242 | K143336 | 000 |
| 00888233001489 | K143336 | 000 |
| 00888233001496 | K143336 | 000 |
| 00888233009997 | K143336 | 000 |
| 00888233010009 | K143336 | 000 |
| 00888233010023 | K143336 | 000 |
| 00888233024976 | K143336 | 000 |
| 00841036181048 | K143336 | 000 |
| 00841036181055 | K143336 | 000 |
| 00841036181062 | K143336 | 000 |
| 00841036181123 | K143336 | 000 |
| 00841036182465 | K143336 | 000 |
| 00841036184353 | K143336 | 000 |
| 00841036197629 | K143336 | 000 |
| 00841036197636 | K143336 | 000 |
| 00888233001472 | K143336 | 000 |