K231744
- 510(k) number
- K231744
- Device name
- VyLink Spinal Screw System
- Applicant
- Vy Spine, LLC FL · US
- Product code
- NKB — Thoracolumbosacral Pedicle Screw System
- Decision date
- 2023-10-13
- Date received
- 2023-06-14
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Orthopedic
PDFDownload 510(k) SummaryArchived here · 0.7 MB · U.S. public domain
Also available from FDA: K231744.pdf
Official FDA record: K231744
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.