510(k) K233951
K233951 is an FDA 510(k) premarket notification submitted by Medtronic Sofamor Danek USA, Inc. for the device "CD Horizon ModuLeX Spinal System (Shanks, Head Assemblies, and Set Screw)". The FDA issued a decision of Substantially Equivalent on March 27, 2024. The device falls under product code NKB (Thoracolumbosacral Pedicle Screw System), a Class II device regulated under 21 CFR 888.3070. Medtronic Sofamor Danek USA, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 27, 2024
- Date Received
- December 15, 2023
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Thoracolumbosacral Pedicle Screw System
- Device Class
- Class II
- Regulation Number
- 888.3070
- Review Panel
- OR
- Submission Type
Intended to provide immobilization and stabilization of spinal segments in thoracic, lumbar, and sacral spine as an adjunct to fusion.