K243007
- 510(k) number
- K243007
- Device name
- CD Horizon Spinal System
- Applicant
- Medtronic Sofamor Danek USA, Inc. TN · US
- Product code
- NKB — Thoracolumbosacral Pedicle Screw System
- Decision date
- 2024-10-23
- Date received
- 2024-09-26
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Orthopedic
PDFDownload 510(k) SummaryArchived here · 0.7 MB · U.S. public domain
Also available from FDA: K243007.pdf
Official FDA record: K243007
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.