K253538
- 510(k) number
- K253538
- Device name
- TeKBrace Knotless Anchor
- Applicant
- Theramicro TN · US
- Product code
- MBI — Fastener, Fixation, Nondegradable, Soft Tissue
- Decision date
- 2026-03-06
- Date received
- 2025-11-13
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Orthopedic
PDFDownload 510(k) SummaryArchived here · 0.9 MB · U.S. public domain
Also available from FDA: K253538.pdf
Official FDA record: K253538
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.