The following data is part of a premarket notification filed by Biomet Microfixation with the FDA for Pectus Support Bar System.
| Device ID | K213712 |
| 510k Number | K213712 |
| Device Name: | Pectus Support Bar System |
| Classification | Plate, Fixation, Bone |
| Applicant | Biomet Microfixation 1520 Tradeport Drive Jacksonville, FL 32218 |
| Contact | Mark Wladkowski |
| Correspondent | Christine Scifert MRC Global 9085 East 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 | 2021-11-24 |
| Decision Date | 2022-03-11 |