CD HORIZON Spinal System, IPC POWEREASE System

Thoracolumbosacral Pedicle Screw System

MEDTRONIC SOFAMOR DANEK USA, INC.

The following data is part of a premarket notification filed by Medtronic Sofamor Danek Usa, Inc. with the FDA for Cd Horizon Spinal System, Ipc Powerease System.

Pre-market Notification Details

• Device ID: K153463
• 510k Number: K153463
• Device Name: CD HORIZON Spinal System, IPC POWEREASE System
• Classification: Thoracolumbosacral Pedicle Screw System
• Applicant: MEDTRONIC SOFAMOR DANEK USA, INC. 1800 PYRAMID PLACE Memphis, TN 38132
• Contact: Becky Ronner
• Correspondent: Becky Ronner; MEDTRONIC SOFAMOR DANEK USA, INC. 1800 PYRAMID PLACE Memphis, TN 38132
• Product Code: NKB
• Subsequent Product Code: HWE
• Subsequent Product Code: KWP
• Subsequent Product Code: KWQ
• Subsequent Product Code: MNH
• Subsequent Product Code: MNI
• Subsequent Product Code: OSH
• CFR Regulation Number: 888.3070 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Special
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2015-12-01
• Decision Date: 2015-12-30
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00643169576995	K153463	000
00643169576841	K153463	000
00643169576834	K153463	000
00643169576827	K153463	000
00643169576810	K153463	000
00643169576803	K153463	000
00643169576797	K153463	000
00643169576780	K153463	000
00643169576773	K153463	000
00643169576766	K153463	000
00643169576759	K153463	000
00643169576742	K153463	000
00643169576735	K153463	000
00643169576858	K153463	000
00643169576865	K153463	000
00643169576988	K153463	000
00643169576971	K153463	000
00643169576964	K153463	000
00643169576957	K153463	000
00643169576940	K153463	000
00643169576933	K153463	000
00643169576926	K153463	000
00643169576919	K153463	000
00643169576902	K153463	000
00643169576896	K153463	000
00643169576889	K153463	000
00643169576872	K153463	000
00643169576728	K153463	000