CD HORIZON SPINAL 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.

Pre-market Notification Details

• Device ID: K132639
• 510k Number: K132639
• Device Name: CD HORIZON SPINAL SYSTEM
• Classification: Thoracolumbosacral Pedicle Screw System
• Applicant: MEDTRONIC SOFAMOR DANEK USA, INC. 1800 PYRAMID PLACE Memphis, TN 38132
• Contact: Shweta Sharma
• Correspondent: Shweta Sharma; MEDTRONIC SOFAMOR DANEK USA, INC. 1800 PYRAMID PLACE Memphis, TN 38132
• Product Code: NKB
• 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: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2013-08-23
• Decision Date: 2013-11-25
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00643169359567	K132639	000
00643169359789	K132639	000
00643169359796	K132639	000
00643169359802	K132639	000
00643169359819	K132639	000
00643169359826	K132639	000
00643169359833	K132639	000
00643169359840	K132639	000
00643169359857	K132639	000
00643169359864	K132639	000
00643169359772	K132639	000
00643169359765	K132639	000
00643169359574	K132639	000
00643169359581	K132639	000
00643169359598	K132639	000
00643169359604	K132639	000
00643169359611	K132639	000
00643169359727	K132639	000
00643169359734	K132639	000
00643169359741	K132639	000
00643169359758	K132639	000
00643169359987	K132639	000
00643169370746	K132639	000
00643169370869	K132639	000
00643169370876	K132639	000
00643169370883	K132639	000
00643169370890	K132639	000
00643169370906	K132639	000
00643169370913	K132639	000
00643169370920	K132639	000
00643169370937	K132639	000
00643169370944	K132639	000
00643169370852	K132639	000
00643169370845	K132639	000
00643169370753	K132639	000
00643169370760	K132639	000
00643169370777	K132639	000
00643169370784	K132639	000
00643169370791	K132639	000
00643169370807	K132639	000
00643169370814	K132639	000
00643169370821	K132639	000
00643169370838	K132639	000
00643169537736	K132639	000