K260989
- 510(k) number
- K260989
- Device name
- Varion Thoracolumbar Fixation System
- Applicant
- Kyocera Medical Technologies Inc. (KMTI) CA · US
- Product code
- NKB — Thoracolumbosacral Pedicle Screw System
- Decision date
- 2026-05-15
- Date received
- 2026-03-25
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Orthopedic
PDFDownload 510(k) SummaryArchived here · 0.5 MB · U.S. public domain
Also available from FDA: K260989.pdf
Official FDA record: K260989
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.