510(k) K203267
K203267 is an FDA 510(k) premarket notification submitted by Biorez, Inc. for the device "The BioBrace Implant". The FDA issued a decision of Substantially Equivalent on April 30, 2021. The device falls under product code OWW (Mesh, Surgical, Absorbable, Orthopaedics, Reinforcement Of Tendon), a Class II device regulated under 21 CFR 878.3300.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 30, 2021
- Date Received
- November 5, 2020
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Mesh, Surgical, Absorbable, Orthopaedics, Reinforcement Of Tendon
- Device Class
- Class II
- Regulation Number
- 878.3300
- Review Panel
- OR
- Submission Type
For reinforcement of soft tissue where weakness exists during tendon repair procedures.