K260216
- 510(k) number
- K260216
- Device name
- CD Horizon ModuLeX Fenestrated Screw Set; CD Horizon ModuLeX Spinal System
- Applicant
- Medtronic Sofamor Danek USA, Inc. TN · US
- Product code
- NKB — Thoracolumbosacral Pedicle Screw System
- Decision date
- 2026-04-21
- Date received
- 2026-01-23
- 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: K260216.pdf
Official FDA record: K260216
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.