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 IDK191066
510k NumberK191066
Device Name:CD Horizon™ Astute™ Spinal System
ClassificationPosterior Metal/polymer Spinal System, Fusion
Applicant Medtronic Sofamor Danek, USA Inc. 1800 Pyramid Place Memphis,  TN  38132
ContactBhavya Vendra
CorrespondentBhavya Vendra
Medtronic Sofamor Danek, USA Inc. 1800 Pyramid Place Memphis,  TN  38132
Product CodeNQP  
Subsequent Product CodeKWP
Subsequent Product CodeKWQ
Subsequent Product CodeNKB
CFR Regulation Number888.3070 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-04-22
Decision Date2019-10-03

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00763000313029 K191066 000
00763000313050 K191066 000
00763000313043 K191066 000
00763000313036 K191066 000
00763000313012 K191066 000
00763000313005 K191066 000
00763000312992 K191066 000
00763000312985 K191066 000
00763000312978 K191066 000
00763000312961 K191066 000
00613994667434 K191066 000
00763000313067 K191066 000
00763000313074 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
00763000313333 K191066 000

Trademark Results [CD Horizon]

Mark Image

Registration | Serial
Company
Trademark
Application Date
CD HORIZON
CD HORIZON
75079759 2108361 Live/Registered
WARSAW ORTHOPEDIC, INC.
1996-03-28

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