Cleared Special

Anteralign(TM) Spinal System with Titan NanoLOCK Surface Technology Navigated Instruments

K221180 · Medtronic Sofamor Danek USA, Inc. · Orthopedic

May 2022

Decision

30d

Days

Class 2

Risk

About This 510(k) Submission

K221180 is an FDA 510(k) clearance for the Anteralign(TM) Spinal System with Titan NanoLOCK Surface Technology Navigated Instruments, a Orthopedic Stereotaxic Instrument (Class II — Special Controls, product code OLO), submitted by Medtronic Sofamor Danek USA, Inc. (Memphis, US). The FDA issued a Cleared decision on May 25, 2022, 30 days after receiving the submission on April 25, 2022. This device falls under the Orthopedic review panel. Regulated under 21 CFR 882.4560.

Submission Details

510(k) Number	K221180 FDA.gov
FDA Decision	Cleared SESE
Date Received	April 25, 2022
Decision Date	May 25, 2022
Days to Decision	30 days
Submission Type	Special
Review Panel	Orthopedic (OR)
Summary	Summary PDF

Device Classification

Product Code	OLO — Orthopedic Stereotaxic Instrument
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 882.4560
Definition	Stereotaxic Guidance During Orthopedic Surgery Procedures. Indicated For Orthopedic Joint Or Spine Surgery. Neurological Stereotaxic Instruments Are Classified Under Product Code Haw.