K240035
- 510(k) number
- K240035
- Device name
- TACTIX Vector Syndesmosis System
- Applicant
- Vilex, LLC TN · US
- Product code
- HTN — Washer, Bolt Nut
- Decision date
- 2024-08-01
- Date received
- 2024-01-04
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Orthopedic
PDFDownload 510(k) SummaryArchived here · 1.4 MB · U.S. public domain
Also available from FDA: K240035.pdf
Official FDA record: K240035
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.