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

Orthopedic Stereotaxic Instrument

Medtronic Sofamor Danek USA, INC.

The following data is part of a premarket notification filed by Medtronic Sofamor Danek Usa, Inc. with the FDA for 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.

Pre-market Notification Details

• Device ID: K214011
• 510k Number: K214011
• Device Name: 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
• Classification: Orthopedic Stereotaxic Instrument
• Applicant: Medtronic Sofamor Danek USA, INC. 1800 Pyramid Place Memphis, TN 38132
• Contact: Alex Underberg
• Correspondent: Alex Underberg; Medtronic Sofamor Danek USA, INC. 1800 Pyramid Place Memphis, TN 38132
• Product Code: OLO
• Subsequent Product Code: HBE
• Subsequent Product Code: MAX
• Subsequent Product Code: OVD
• CFR Regulation Number: 882.4560 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Special
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2021-12-22
• Decision Date: 2022-02-09

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00763000611286	K214011	000
00763000611279	K214011	000