The following data is part of a premarket notification filed by Biomet Microfixation with the FDA for Biomet Microfixation Ribfix Blu Thoracic Fixation System.
| Device ID | K162974 |
| 510k Number | K162974 |
| Device Name: | Biomet Microfixation RibFix Blu Thoracic Fixation System |
| Classification | Plate, Fixation, 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 | HRS |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-10-25 |
| Decision Date | 2016-12-09 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00841036235178 | K162974 | 000 |
| 00841036244187 | K162974 | 000 |
| 00841036230425 | K162974 | 000 |
| 00888233000185 | K162974 | 000 |
| 00888233000178 | K162974 | 000 |