CD HORIZON® Spinal System

GUDID 00613994324030

SPACER X090602808 8MM X 30MM

MEDTRONIC SOFAMOR DANEK, INC.

Vertebral body prosthesis
Primary Device ID00613994324030
NIH Device Record Key3f0f0e71-ab2e-4dc4-968e-c5ce5467df46
Commercial Distribution StatusIn Commercial Distribution
Brand NameCD HORIZON® Spinal System
Version Model NumberX090602808
Company DUNS830350380
Company NameMEDTRONIC SOFAMOR DANEK, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com

Device Dimensions

Length30 Millimeter
Length30 Millimeter
Length30 Millimeter
Length30 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS100613994324030 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MQPSPINAL VERTEBRAL BODY REPLACEMENT DEVICE

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00613994324030]

Moist Heat or Steam Sterilization

[00613994324030]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2020-02-24
Device Publish Date2015-08-21

On-Brand Devices [CD HORIZON® Spinal System]

00613994953216SCR X1010761 5.5 RED SAS TI OGTHN 8.0X95
00613994953209SCR X1010762 5.5 RED SAS TI OG 8.0X100
00613994953193SCR X1010750 5.5 RED SAS TI OGTHN 8.0X40
00613994953186SCR X1010738 5.5 RED SAS TI OGTHN 7.5X65
00613994953179SCR X1010739 5.5 RED SAS TI OGTHN 7.5X70
00613994953162SCR X1010740 5.5 RED SAS TI OGTHN 7.5X75
00613994953155SCR X1010741 5.5 RED SAS TI OGTHN 7.5X80
00613994953148SCR X1010742 5.5 RED SAS TI OGTHN 7.5X85
00613994953131SCR X1010743 5.5 RED SAS TI OGTHN 7.5X90
00613994953124SCR X1010744 5.5 RED SAS TI OGTHN 7.5X95
00613994953117SCR X1010745 5.5 RED SAS TI OG 7.5X100
00613994953100SCR X1010746 5.5 RED SAS TI OGTHN 8.0X20
00613994953094SCR X1010747 5.5 RED SAS TI OGTHN 8.0X25
00613994953087SCR X1010748 5.5 RED SAS TI OGTHN 8.0X30
00613994953070SCR X1010749 5.5 RED SAS TI OGTHN 8.0X35
00613994951021SCREW 54890007585 4.75 RMAS 7.5X85 CC
00613994951014SCREW 54890007590 4.75 RMAS 7.5X90 CC
00613994951007SCREW 54890007595 4.75 RMAS 7.5X95 CC
00613994950994SCREW 54890008000 4.75 RMAS 8.0X100 CC
00613994950987SCREW 54890008011 4.75 RMAS 8.0X110 CC
00613994950963SCREW 54890008085 4.75 RMAS 8.0X85 CC
00613994950956SCREW 54890008090 4.75 RMAS 8.0X90 CC
00613994950949SCREW 54890008095 4.75 RMAS 8.0X95 CC
00613994950932SCREW 54890008500 4.75 RMAS 8.5X100 CC
00613994950925SCREW 54890008511 4.75 RMAS 8.5X110 CC
00613994950901SCREW 54890008520 4.75 RMAS 8.5X20 CC
00613994950895SCREW 54890008525 4.75 RMAS 8.5X25 CC
00613994950888SCREW 54890008530 4.75 RMAS 8.5X30 CC
00613994950871SCREW 54890008535 4.75 RMAS 8.5X35 CC
00613994950864SCREW 54890008540 4.75 RMAS 8.5X40 CC
00613994950857SCREW 54890008545 4.75 RMAS 8.5X45 CC
00613994950840SCREW 54890008550 4.75 RMAS 8.5X50 CC
00613994950833SCREW 54890008555 4.75 RMAS 8.5X55 CC
00613994950826SCREW 54890008560 4.75 RMAS 8.5X60 CC
00613994950819SCREW 54890007511 4.75 RMAS 7.5X110 CC
00613994950802SCREW 54890001000 4.75 RMAS 10.0X100 CC
00613994950796SCREW 54890001011 4.75 RMAS 10.0X110 CC
00613994950772SCREW 54890001080 4.75 RMAS 10.0X80 CC
00613994950765SCREW 54890001085 4.75 RMAS 10.0X85 CC
00613994950758SCREW 54890001090 4.75 RMAS 10.0X90 CC
00613994950741SCREW 54890001095 4.75 RMAS 10.0X95 CC
00613994950734SCREW 54890001500 4.75 RMAS 10.5X100 CC
00613994950727SCREW 54890001511 4.75 RMAS 10.5X110 CC
00613994950703SCREW 54890001580 4.75 RMAS 10.5X80 CC
00613994950697SCREW 54890001585 4.75 RMAS 10.5X85 CC
00613994950680SCREW 54890001590 4.75 RMAS 10.5X90 CC
00613994950673SCREW 54890001595 4.75 RMAS 10.5X95 CC
00613994950666SCREW 54890004015 4.75 RMAS 4.0X15 CC
00613994950659SCREW 54890004515 4.75 RMAS 4.5X15 CC
00613994950642SCREW 54890005015 4.75 RMAS 5.0X15 CC

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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