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: K163301
• 510k Number: K163301
• Device Name: CD HORIZON® Spinal System
• Classification: Thoracolumbosacral Pedicle Screw System
• Applicant: Medtronic Sofamor Danek USA, Inc. 1800 Pyramid Place Memphis, TN 38132
• Contact: Justin O'connor
• Correspondent: Justin E. O'connor; 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: Special
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2016-11-22
• Decision Date: 2016-12-20
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00643169841529	K163301	000
00643169841390	K163301	000
00643169841383	K163301	000
00643169841376	K163301	000
00643169841369	K163301	000
00643169841352	K163301	000
00643169841345	K163301	000
00643169841338	K163301	000
00643169841321	K163301	000
00643169841314	K163301	000
00643169841307	K163301	000
00643169841406	K163301	000
00643169841413	K163301	000
00643169841512	K163301	000
00643169841505	K163301	000
00643169841499	K163301	000
00643169841482	K163301	000
00643169841475	K163301	000
00643169841468	K163301	000
00643169841451	K163301	000
00643169841444	K163301	000
00643169841437	K163301	000
00643169841420	K163301	000
00643169841291	K163301	000