K251063
- 510(k) number
- K251063
- Device name
- TekBrace Solo Soft Tissue Reinforcement Device
- Applicant
- Theramicro TN · US
- Product code
- QUW — Mesh, Surgical, Non-Resorbable, Orthopedics, Reinfor
- Decision date
- 2025-05-30
- Date received
- 2025-04-04
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- General, Plastic Surgery
PDFDownload 510(k) SummaryArchived here · 0.7 MB · U.S. public domain
Also available from FDA: K251063.pdf
Official FDA record: K251063
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.