510(k) clearance
TeKBrace Knotless Anchor
- 510(k) number
- K263352
- Applicant
- TheraMicro
- Decision date
- Oct 21, 2026
- Date received
- Sep 23, 2026
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Product code
- MBI
- Device type
- Fastener, Fixation, Nondegradable, Soft Tissue
- Device class
- Class II
- Regulation
- 21 CFR 888.3040
- Advisory committee
- Orthopedic
- Statement or summary
- Summary
- Third party
- N
- Location
- Cordova, TN, US