Anteralign™ LS Spinal System With Titan NanoLOCK™ Surface Technology MAZORX Stealth(TM) Edition

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 Anteralign™ Ls Spinal System With Titan Nanolock™ Surface Technology Mazorx Stealth(tm) Edition.

Pre-market Notification Details

• Device ID: K222383
• 510k Number: K222383
• Device Name: Anteralign™ LS Spinal System With Titan NanoLOCK™ Surface Technology MAZORX Stealth(TM) Edition
• Classification: Orthopedic Stereotaxic Instrument
• Applicant: Medtronic Sofamor Danek USa, Inc. 1800 Pyramid Place Memphis, TN 38132
• Contact: Elizabeth Hamilton
• Correspondent: Elizabeth Hamilton; Medtronic Sofamor Danek USa, Inc. 1800 Pyramid Place Memphis, TN 38132
• Product Code: OLO
• CFR Regulation Number: 882.4560 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Special
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2022-08-05
• Decision Date: 2022-09-29