TekBrace Solo Soft Tissue Reinforcement Device— 510(k) K261621
Substantially EquivalentTheramicro
FDA 510(k) clearance K261621 for TekBrace Solo Soft Tissue Reinforcement Device, Substantially Equivalent on 2026-06-09. Applicant: Theramicro. Device class: 2.
Summary
Theramicro's TekBrace Solo Soft Tissue Reinforcement Device is filed under QUW, non-resorbable surgical mesh for ligament reinforcement in orthopedics. The record gives no sizes or model numbers.
Class II, 21 CFR 878.3300. The Orthopedic review panel handled it as a Special 510(k); the record lists General and Plastic Surgery as the classification panel.
Theramicro filed from Cordova, Tennessee. Review took 25 calendar days (May 15 to June 9, 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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