Cleared Traditional

Anteralign Spinal System with Titan nanoLOCK Surface Technology

K212524 · Medtronic Sofamor Danek USA, Inc. · Orthopedic

Dec 2021

Decision

119d

Days

Class 2

Risk

About This 510(k) Submission

K212524 is an FDA 510(k) clearance for the Anteralign Spinal System with Titan nanoLOCK Surface Technology, a Intervertebral Fusion Device With Bone Graft, Lumbar (Class II — Special Controls, product code MAX), submitted by Medtronic Sofamor Danek USA, Inc. (Memphis, US). The FDA issued a Cleared decision on December 8, 2021, 119 days after receiving the submission on August 11, 2021. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3080.

Submission Details

510(k) Number	K212524 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 11, 2021
Decision Date	December 08, 2021
Days to Decision	119 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF

Device Classification

Product Code	MAX — Intervertebral Fusion Device With Bone Graft, Lumbar
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 888.3080
Definition	Intended To Stabilize Spinal Segment To Promote Fusion In Order To Restrict Motion And Decrease Pain Using Bone Graft.