K253169
- 510(k) number
- K253169
- Device name
- Duet Spinal Fixation System
- Applicant
- Box Spine, LLC OK · US
- Product code
- NKB — Thoracolumbosacral Pedicle Screw System
- Decision date
- 2026-02-23
- Date received
- 2025-09-26
- 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: K253169.pdf
Official FDA record: K253169
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.