K253335
- 510(k) number
- K253335
- Device name
- CD Horizon Spinal System
- Applicant
- Medtronic Sofamor Danek USA, Inc. TN · US
- Product code
- NKB — Thoracolumbosacral Pedicle Screw System
- Decision date
- 2025-10-24
- Date received
- 2025-09-30
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Orthopedic
PDFDownload 510(k) SummaryArchived here · 1.0 MB · U.S. public domain
Also available from FDA: K253335.pdf
Official FDA record: K253335
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.