Cleared Traditional

CD HORIZON? Spinal System, Medtronic Reusable Instruments for Use with the IPC? POWEREASE? System, Medtronic Navigated Reusable Instruments for Use with the STEALTHSTATION? and IPC? POWEREASE? Systems

K170679 · Medtronic Sofamor Danek · Orthopedic

May 2017

Decision

66d

Days

Class 2

Risk

About This 510(k) Submission

K170679 is an FDA 510(k) clearance for the CD HORIZON? Spinal System, Medtronic Reusable Instruments for Use with the IPC? POWEREASE? System, Medtronic Navigated Reusable Instruments for Use with the STEALTHSTATION? and IPC? POWEREASE? Systems, a Thoracolumbosacral Pedicle Screw System (Class II — Special Controls, product code NKB), submitted by Medtronic Sofamor Danek (Memphis, US). The FDA issued a Cleared decision on May 11, 2017, 66 days after receiving the submission on March 6, 2017. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3070.

Submission Details

510(k) Number	K170679 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 06, 2017
Decision Date	May 11, 2017
Days to Decision	66 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF

Device Classification

Product Code	NKB — Thoracolumbosacral Pedicle Screw System
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 888.3070
Definition	Intended To Provide Immobilization And Stabilization Of Spinal Segments In Thoracic, Lumbar, And Sacral Spine As An Adjunct To Fusion.