K233951
- 510(k) number
- K233951
- Device name
- CD Horizon ModuLeX Spinal System (Shanks, Head Assemblies, and Set Screw)
- Applicant
- Medtronic Sofamor Danek USA, Inc. TN · US
- Product code
- NKB — Thoracolumbosacral Pedicle Screw System
- Decision date
- 2024-03-27
- Date received
- 2023-12-15
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Orthopedic
PDFDownload 510(k) SummaryArchived here · 2.5 MB · U.S. public domain
Also available from FDA: K233951.pdf
Official FDA record: K233951
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.