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 | K151173 |
| 510k Number | K151173 |
| Device Name: | Biomet Microfixation RibFix Blu Thoracic Fixation System |
| Classification | Screw, 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 | HWC |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-05-01 |
| Decision Date | 2015-05-26 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00841036197971 | K151173 | 000 |
| 00888233024761 | K151173 | 000 |
| 00888233024754 | K151173 | 000 |
| 00888233024747 | K151173 | 000 |
| 00888233024730 | K151173 | 000 |
| 00888233024723 | K151173 | 000 |
| 00888233024716 | K151173 | 000 |
| 00888233024655 | K151173 | 000 |
| 00888233001373 | K151173 | 000 |
| 00888233001328 | K151173 | 000 |
| 00888233001311 | K151173 | 000 |
| 00888233001304 | K151173 | 000 |
| 00888233001298 | K151173 | 000 |
| 00888233001281 | K151173 | 000 |
| 00888233001274 | K151173 | 000 |
| 00888233024778 | K151173 | 000 |
| 00841036184186 | K151173 | 000 |
| 00841036197957 | K151173 | 000 |
| 00841036197940 | K151173 | 000 |
| 00841036197933 | K151173 | 000 |
| 00841036197926 | K151173 | 000 |
| 00841036197919 | K151173 | 000 |
| 00841036197902 | K151173 | 000 |
| 00841036197841 | K151173 | 000 |
| 00841036197582 | K151173 | 000 |
| 00841036197575 | K151173 | 000 |
| 00841036197568 | K151173 | 000 |
| 00841036197551 | K151173 | 000 |
| 00841036197544 | K151173 | 000 |
| 00841036197537 | K151173 | 000 |
| 00841036184247 | K151173 | 000 |
| 00888233001212 | K151173 | 000 |