510(k) K203267
- Device
- The BioBrace Implant
- Applicant
- Biorez, Inc.
- 510(k) number
- K203267
- Product code
- OWT
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2021-04-30
- Date received
- 2020-11-05
- Regulation
- 878.3300
- Classification name
- Mesh, Surgical, Absorbable, Abdominal Hernia
- Medical specialty
- General & Plastic Surgery
- Review panel
- Orthopedic
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Kevin Rocco
- Address
- 470 James St., Suite 14 New Haven CT US 06513 06513
FDA Registration Numbers#
- 8043792
- 1721676
- 3019101334
- 1064858
- 9614442
- 3033302333
- 3000215346
- 1320894
- 2030598
- 3009493875
- 3027699572
- 3010673515
- 3012669262
- 1017294
- 3033273526
- 3014527904
Source Documents#
Other 510(k) Records For Product Code OWT #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K243241 | Phasix ST Umbilical Hernia Patch | Davol, Inc., A Subsidiary of C.R. Bard, Inc. | 2025-02-19 |
| K233661 | Transorb™ Self-Gripping Resorbable Mesh | Sofradim Production | 2024-02-13 |
| K191749 | TIGR Matrix Surgical Mesh, TIGR Surgical Mesh | Novus Scientific AB | 2020-03-26 |
| K191773 | GORE BIO-A Tissue Reinforcement | W. L. Gore & Associates, Inc. | 2019-07-31 |
| K190185 | Phasix ST Mesh with Open Positioning System | C.R. Bard, Inc. | 2019-06-12 |
| K173143 | Phasix ST Mesh | C.R. Bard, Inc. | 2018-04-25 |
| K163005 | TIGR Matrix Surgical Mesh | Novus Scientific AB | 2017-07-27 |
| K143380 | Phasix ST Mesh | C.R. Bard, Inc. | 2015-06-05 |
| K120728 | PHASIX PLUG AND PATCH | C.R. Bard, Inc. | 2012-10-22 |
| K101287 | TEPHAFLEX COMPOSITE MESH | Tepha, Inc. | 2010-08-30 |
| K033671 | GORE BIOABSORBABLE MESH | W. L. Gore & Associates, Inc. | 2003-12-31 |
Legacy Summary#
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FDA Review#
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