Clearance Summary
Catalyft PL Expandable Interbody System Navigated Instruments, Anteralign TL Spinal System with Titan nanoLOCK Surface Technology Navigated Instruments, and CD Horizon Solera Voyager Spinal System Navigated, Guided, and Powered Drivers received FDA 510(k) clearance under submission number K214011, sponsored by Medtronic Sofamor Danek USA, Inc.. The device was reviewed via the Special premarket notification pathway and assigned to the Neurology review panel. The statutory decision date of record is 2022-02-09.
- Submission: K214011
- Applicant / Sponsor: Medtronic Sofamor Danek USA, Inc.
- Clearance pathway: Special
- Review panel: Neurology
- Device class: Class II
- Regulation citation: 21 CFR 882.4560
- Decision date: 2022-02-09
Classification & Regulation
This clearance is catalogued under FDA product code OLO and 21 CFR 882.4560, within the Neurology review panel as a Class II device.