Cleared Special

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

K214011 · Medtronic Sofamor Danek USA, Inc. · Orthopedic

Feb 2022

Decision

49d

Days

Class 2

Risk

About This 510(k) Submission

K214011 is an FDA 510(k) clearance for the 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, 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 February 9, 2022, 49 days after receiving the submission on December 22, 2021. This device falls under the Orthopedic review panel. Regulated under 21 CFR 882.4560.

Submission Details

510(k) Number	K214011 FDA.gov
FDA Decision	Cleared SESE
Date Received	December 22, 2021
Decision Date	February 09, 2022
Days to Decision	49 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.