The following data is part of a premarket notification filed by Biomet Micofixation with the FDA for Biomet Microfixation Ribfix Advantage System.
| Device ID | K203474 |
| 510k Number | K203474 |
| Device Name: | Biomet Microfixation RibFix Advantage System |
| Classification | Plate, Fixation, Bone |
| Applicant | Biomet Micofixation 1520 Tradeport Drive Jacksonville, FL 32218 |
| Contact | Lauren Jasper |
| Correspondent | Lauren Jasper Biomet Micofixation 1520 Tradeport Drive Jacksonville, FL 32218 |
| Product Code | HRS |
| Subsequent Product Code | HTN |
| Subsequent Product Code | HWC |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-11-25 |
| Decision Date | 2021-01-28 |