TeKBrace Solo Soft Tissue Reinforcement Device— 510(k) K262729
Substantially EquivalentTheramicro
FDA 510(k) clearance K262729 for TeKBrace Solo Soft Tissue Reinforcement Device, Substantially Equivalent on 2026-08-18. Applicant: Theramicro. Device class: 2.
Summary
Theramicro filed the TeKBrace Solo Soft Tissue Reinforcement Device under product code QUW (Mesh, Surgical, Non-Resorbable, Orthopedics, Reinforcement Of Ligament). No model numbers are listed.
Class II, 21 CFR 878.3300. The Orthopedic review panel handled it as a Special 510(k), though the record lists General and Plastic Surgery as the classification panel.
Theramicro filed from Cordova, Tennessee. FDA found it substantially equivalent 18 calendar days after receipt (July 31 to August 18, 2026).
Clearance details
- Applicant
- Theramicro
- Product code
- Product code QUW
- Device class
- Class 2
- Regulation
- 21 CFR 878.3300
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Cordova, TN, US
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