K261621
- 510(k) number
- K261621
- Device name
- TekBrace Solo Soft Tissue Reinforcement Device
- Applicant
- Theramicro TN · US
- Product code
- QUW — Mesh, Surgical, Non-Resorbable, Orthopedics, Reinfor
- Decision date
- 2026-06-09
- Date received
- 2026-05-15
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- General, Plastic Surgery
PDFDownload 510(k) SummaryArchived here · 1.7 MB · U.S. public domain
Also available from FDA: K261621.pdf
Official FDA record: K261621
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.