CD HORIZON® SOLERA® VOYAGER™ Spinal System

GUDID 00763000611286

DRIVER RBT036402 5.5/6.0 SV SAS LONG

MEDTRONIC SOFAMOR DANEK, INC.

Surgical screwdriver, reusable Surgical screwdriver, reusable Surgical screwdriver, reusable Surgical screwdriver, reusable Surgical screwdriver, reusable Surgical screwdriver, reusable Surgical screwdriver, reusable Surgical screwdriver, reusable Surgical screwdriver, reusable Surgical screwdriver, reusable Surgical screwdriver, reusable Surgical screwdriver, reusable
Primary Device ID00763000611286
NIH Device Record Keybf6365b8-8612-4583-b317-9645221c1339
Commercial Distribution StatusIn Commercial Distribution
Brand NameCD HORIZON® SOLERA® VOYAGER™ Spinal System
Version Model NumberRBT036402
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 Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Countertrue

Customer Support Contacts

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

Device Identifiers

Device Issuing AgencyDevice ID
GS100763000611286 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

OLOOrthopedic stereotaxic instrument

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00763000611286]

Moist Heat or Steam Sterilization

[00763000611286]

Moist Heat or Steam Sterilization

[00763000611286]

Moist Heat or Steam Sterilization

[00763000611286]

Moist Heat or Steam Sterilization

[00763000611286]

Moist Heat or Steam Sterilization

[00763000611286]

Moist Heat or Steam Sterilization

[00763000611286]

Moist Heat or Steam Sterilization

[00763000611286]

Moist Heat or Steam Sterilization

[00763000611286]

Moist Heat or Steam Sterilization

[00763000611286]

Moist Heat or Steam Sterilization

[00763000611286]

Moist Heat or Steam Sterilization

[00763000611286]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-05-16
Device Publish Date2022-05-06

On-Brand Devices [CD HORIZON® SOLERA® VOYAGER™ Spinal System]

00643169890008TRAY 1664021 4.75 CDHSV GEN INSTRUMENTS
00643169886551LID 1664022 TAB EXTENDER CADDY LID
00643169885134TRAY 1664019 CDHS VOYAGER 4.75 ATS
00643169880214SCREW 55850014515 5.5 VOYAGER MAS 4.5X15
00643169880207SCREW 54750047560 SV 4.75 ATS 7.5X60 ST
00643169880191SCREW 54750047555 SV 4.75 ATS 7.5X55 ST
00643169880184SCREW 54750047550 SV 4.75 ATS 7.5X50 ST
00643169880177SCREW 54750047545 SV 4.75 ATS 7.5X45 ST
00643169880160SCREW 54750047540 SV 4.75 ATS 7.5X40 ST
00643169880153SCREW 54750047535 SV 4.75 ATS 7.5X35 ST
00643169880146SCREW 54750047530 SV 4.75 ATS 7.5X30 ST
00643169880139SCREW 54750047525 SV 4.75 ATS 7.5X25 ST
00643169880122SCREW 54750047520 SV 4.75 ATS 7.5X20 ST
00643169880115SCREW 54750046560 SV 4.75 ATS 6.5X60 ST
00643169880108SCREW 54750046555 SV 4.75 ATS 6.5X55 ST
00643169880092SCREW 54750046550 SV 4.75 ATS 6.5X50 ST
00643169880085SCREW 54750046545 SV 4.75 ATS 6.5X45 ST
00643169880078SCREW 54750046540 SV 4.75 ATS 6.5X40 ST
00643169880061SCREW 54750046535 SV 4.75 ATS 6.5X35 ST
00643169880054SCREW 54750046530 SV 4.75 ATS 6.5X30 ST
00643169880047SCREW 54750046525 SV 4.75 ATS 6.5X25 ST
00643169880030SCREW 54750046520 SV 4.75 ATS 6.5X20 ST
00643169880023SCREW 54750045560 SV 4.75 ATS 5.5X60 ST
00643169880016SCREW 54750045555 SV 4.75 ATS 5.5X55 ST
00643169880009SCREW 54750045550 SV 4.75 ATS 5.5X50 ST
00643169879997SCREW 54750045545 SV 4.75 ATS 5.5X45 ST
00643169879980SCREW 54750045540 SV 4.75 ATS 5.5X40 ST
00643169879973SCREW 54750045535 SV 4.75 ATS 5.5X35 ST
00643169879966SCREW 54750045530 SV 4.75 ATS 5.5X30 ST
00643169879959SCREW 54750045525 SV 4.75 ATS 5.5X25 ST
00643169879942SCREW 54750045520 SV 4.75 ATS 5.5X20 ST
00643169879935SCREW 54750044560 SV 4.75 ATS 4.5X60 ST
00643169879928SCREW 54750044555 SV 4.75 ATS 4.5X55 ST
00643169879911SCREW 54750044550 SV 4.75 ATS 4.5X50 ST
00643169879904SCREW 54750044545 SV 4.75 ATS 4.5X45 ST
00643169879898SCREW 54750044540 SV 4.75 ATS 4.5X40 ST
00643169879881SCREW 54750044535 SV 4.75 ATS 4.5X35 ST
00643169879874SCREW 54750044530 SV 4.75 ATS 4.5X30 ST
00643169879867SCREW 54750044525 SV 4.75 ATS 4.5X25 ST
00643169879850SCREW 54750044520 SV 4.75 ATS 4.5X20 ST
00643169833944SCREW 54850047560 4.75VOYAGER ATS 7.5X60
00643169833937SCREW 54850047530 4.75VOYAGER ATS 7.5X30
00643169833920SCREW 54850047525 4.75VOYAGER ATS 7.5X25
00643169833913SCREW 54850047520 4.75VOYAGER ATS 7.5X20
00643169833906SCREW 54850046560 4.75VOYAGER ATS 6.5X60
00643169833890SCREW 54850046555 4.75VOYAGER ATS 6.5X55
00643169833883SCREW 54850046525 4.75VOYAGER ATS 6.5X25
00643169833876SCREW 54850046520 4.75VOYAGER ATS 6.5X20
00643169833869SCREW 54850045560 4.75VOYAGER ATS 5.5X60
00643169833852SCREW 54850045555 4.75VOYAGER ATS 5.5X55

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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