CD Horizon™ Astute™ Spinal System

Posterior Metal/polymer Spinal System, Fusion

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™ Astute™ Spinal System.

Pre-market Notification Details

• Device ID: K191066
• 510k Number: K191066
• Device Name: CD Horizon™ Astute™ Spinal System
• Classification: Posterior Metal/polymer Spinal System, Fusion
• Applicant: Medtronic Sofamor Danek, USA Inc. 1800 Pyramid Place Memphis, TN 38132
• Contact: Bhavya Vendra
• Correspondent: Bhavya Vendra; Medtronic Sofamor Danek, USA Inc. 1800 Pyramid Place Memphis, TN 38132
• Product Code: NQP
• Subsequent Product Code: KWP
• Subsequent Product Code: KWQ
• Subsequent Product Code: NKB
• CFR Regulation Number: 888.3070 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2019-04-22
• Decision Date: 2019-10-03

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00763000313029	K191066	000
00763000313012	K191066	000
00763000313005	K191066	000
00763000312992	K191066	000
00763000312985	K191066	000
00763000312978	K191066	000
00763000312961	K191066	000
00613994667434	K191066	000
00763000313333	K191066	000
00643169281264	K191066	000
00643169281110	K191066	000
00643169281165	K191066	000
00643169281226	K191066	000
00643169281202	K191066	000
00763000313036	K191066	000
00763000313043	K191066	000
00763000312954	K191066	000
00763000312947	K191066	000
00763000312930	K191066	000
00763000312923	K191066	000
00763000312916	K191066	000
00763000313128	K191066	000
00763000313111	K191066	000
00763000313104	K191066	000
00763000313098	K191066	000
00763000313081	K191066	000
00763000313074	K191066	000
00763000313067	K191066	000
00763000313050	K191066	000
00643169281172	K191066	000