The BioBrace Implant
FDA 510(k) clearance K203267 · decided 2021-04-30
Clearance details
- K-number
- K203267
- Device name
- The BioBrace Implant
- Applicant
- Biorez, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2020-11-05
- Decision date
- 2021-04-30
- Days to decision
- 176 days
- Clearance type
- Traditional
- Product code
- OWW
- Device class
- 2
- Regulation number
- 878.3300
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- New Haven, CT, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| VersaCoat Tendon Protector (VTP-44G2); VersaCoat Tendon Protector (VTP-12G1) (K251655) | Alafair Biosciences | 2025-07-18 |
| Rotium (K250021) | Nanofiber Solutions, LLC | 2025-02-27 |
| BioBrace® (K242187) | Conmed Corporation | 2024-11-27 |
| BioBrace® Reinforced Implant (K241906) | Conmed Corporation | 2024-07-29 |
| VersaWrap (K240817) | Alafair Biosciences, Inc. | 2024-06-14 |
| SpinMedix Absorbable Fibrous Membrane (K222220) | Celestray Biotech Company, LLC., | 2023-07-06 |
| FlexBand; FlexPatch; FlexBand Plus (K230316) | International Life Sciences | 2023-05-26 |
| VersaWrap Tendon Protector (K160364) | Alafair Biosciences, Inc. | 2016-06-10 |
| STR GRAFT (K121216) | Soft Tissue Regeneration, Inc. | 2012-11-21 |
Recalls involving this device
No recalls on record reference this clearance.