Anteralign Spinal System With Titan NanoLOCK Surface Technology

Intervertebral Fusion Device With Bone Graft, Lumbar

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 Spinal System With Titan Nanolock Surface Technology.

Pre-market Notification Details

• Device ID: K212524
• 510k Number: K212524
• Device Name: Anteralign Spinal System With Titan NanoLOCK Surface Technology
• Classification: Intervertebral Fusion Device With Bone Graft, Lumbar
• 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: MAX
• Subsequent Product Code: OLO
• Subsequent Product Code: OVD
• CFR Regulation Number: 888.3080 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2021-08-11
• Decision Date: 2021-12-08

NIH GUDID Devices

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