510(k) K251063
K251063 is an FDA 510(k) premarket notification submitted by Theramicro for the device "TekBrace Solo Soft Tissue Reinforcement Device". The FDA issued a decision of Substantially Equivalent on May 30, 2025. The device falls under product code QUW (Mesh, Surgical, Non-Resorbable, Orthopedics, Reinforcement Of Ligament), a Class II device regulated under 21 CFR 878.3300. Theramicro has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 30, 2025
- Date Received
- April 4, 2025
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Mesh, Surgical, Non-Resorbable, Orthopedics, Reinforcement Of Ligament
- Device Class
- Class II
- Regulation Number
- 878.3300
- Review Panel
- OR
- Submission Type
a non-resorbable orthopedic mesh used for reinforcement of soft tissue where weakness exists in ligament repair.