Cleared Special

CD HORIZON SPIRE Z SPINAL SYSTEM

K123246 · Medtronic Sofamor Danek · Orthopedic

Nov 2012

Decision

30d

Days

Class 2

Risk

About This 510(k) Submission

K123246 is an FDA 510(k) clearance for the CD HORIZON SPIRE Z SPINAL SYSTEM, 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 November 16, 2012, 30 days after receiving the submission on October 17, 2012. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3070.

Submission Details

510(k) Number	K123246 FDA.gov
FDA Decision	Cleared SESU
Date Received	October 17, 2012
Decision Date	November 16, 2012
Days to Decision	30 days
Submission Type	Special
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.