CD Horizon™ Spinal System

Thoracolumbosacral Pedicle Screw System

Medtronic

The following data is part of a premarket notification filed by Medtronic with the FDA for Cd Horizon™ Spinal System.

Pre-market Notification Details

Device IDK221244
510k NumberK221244
Device Name:CD Horizon™ Spinal System
ClassificationThoracolumbosacral Pedicle Screw System
Applicant Medtronic 1800 Pyramid Place Memphis,  TN  38132
ContactJustin O'Connor
CorrespondentJustin O'Connor
Medtronic 1800 Pyramid Place Memphis,  TN  38132
Product CodeNKB  
Subsequent Product CodeHBE
Subsequent Product CodeKWP
Subsequent Product CodeKWQ
Subsequent Product CodeOLO
CFR Regulation Number888.3070 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2022-05-02
Decision Date2022-05-25

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00763000586041 K221244 000
00763000825874 K221244 000
00763000825935 K221244 000
00763000825959 K221244 000
00763000825966 K221244 000
00763000825973 K221244 000
00763000845001 K221244 000
00763000608507 K221244 000
00763000587338 K221244 000
00763000592196 K221244 000
00763000583767 K221244 000
00763000583781 K221244 000
00763000733513 K221244 000
00763000585969 K221244 000
00763000585976 K221244 000
00763000585983 K221244 000
00763000585990 K221244 000
00763000825867 K221244 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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