The following data is part of a premarket notification filed by Biomet Micofixation with the FDA for Pectus Blu Support Bar System.
| Device ID | K212841 |
| 510k Number | K212841 |
| Device Name: | Pectus Blu Support Bar System |
| Classification | Plate, Fixation, Bone |
| Applicant | Biomet Micofixation 1520 Tradeport Drive Jacksonville, FL 32218 |
| Contact | Mark Wladowski |
| Correspondent | Danielle Besal MRC Global, LLC 9085 E Mineral Circle, Suite 110 Centennial, CO 80112 |
| Product Code | HRS |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-09-07 |
| Decision Date | 2022-01-07 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00888233037860 | K212841 | 000 |
| 00888233032599 | K212841 | 000 |
| 00888233032582 | K212841 | 000 |
| 00888233032575 | K212841 | 000 |
| 00888233032568 | K212841 | 000 |
| 00888233032551 | K212841 | 000 |
| 00888233028950 | K212841 | 000 |
| 00888233028943 | K212841 | 000 |
| 00888233028868 | K212841 | 000 |
| 00888233028851 | K212841 | 000 |
| 00888233028844 | K212841 | 000 |
| 00888233028837 | K212841 | 000 |
| 00888233028813 | K212841 | 000 |
| 00888233028806 | K212841 | 000 |
| 00888233028790 | K212841 | 000 |
| 00888233028783 | K212841 | 000 |
| 00888233032605 | K212841 | 000 |
| 00888233032612 | K212841 | 000 |
| 00888233032629 | K212841 | 000 |
| 00888233032858 | K212841 | 000 |
| 00888233032834 | K212841 | 000 |
| 00888233032759 | K212841 | 000 |
| 00888233032742 | K212841 | 000 |
| 00888233032735 | K212841 | 000 |
| 00888233032728 | K212841 | 000 |
| 00888233032711 | K212841 | 000 |
| 00888233032704 | K212841 | 000 |
| 00888233032698 | K212841 | 000 |
| 00888233032681 | K212841 | 000 |
| 00888233032674 | K212841 | 000 |
| 00888233032667 | K212841 | 000 |
| 00888233032650 | K212841 | 000 |
| 00888233032643 | K212841 | 000 |
| 00888233032636 | K212841 | 000 |
| 00888233028776 | K212841 | 000 |