The following data is part of a premarket notification filed by Biorez, Inc. with the FDA for The Biobrace Implant.
| Device ID | K203267 |
| 510k Number | K203267 |
| Device Name: | The BioBrace Implant |
| Classification | Mesh, Surgical, Absorbable, Abdominal Hernia |
| Applicant | Biorez, Inc. 470 James Street, Suite 14 New Haven, CT 06513 |
| Contact | Kevin Rocco |
| Correspondent | Robert A Poggie BioVera, Inc. 65 Promenade Saint Louis Notre Dame De L'lle Perrot, CA J7v7p2 |
| Product Code | OWT |
| CFR Regulation Number | 878.3300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-11-05 |
| Decision Date | 2021-04-30 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00860006566715 | K203267 | 000 |
| 00860006566708 | K203267 | 000 |
| 10653405988960 | K203267 | 000 |
| 10653405988953 | K203267 | 000 |
| 10653405988939 | K203267 | 000 |