510(k) clearance
TeKBrace Solo Soft Tissue Reinforcement Device
- 510(k) number
- K262729
- Applicant
- Theramicro
- Decision date
- Aug 18, 2026
- Date received
- Jul 31, 2026
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Product code
- QUW
- Device type
- Mesh, Surgical, Non-Resorbable, Orthopedics, Reinforcement Of Ligament
- Device class
- Class II
- Regulation
- 21 CFR 878.3300
- Advisory committee
- General, Plastic Surgery
- Statement or summary
- Summary
- Third party
- N
- Location
- Cordova, TN, US