CD HORIZON® SOLERA® VOYAGER™ Spinal System

GUDID 00643169783959

SCREW 55750018535 5.5VOYAGER STMAS8.5X35

MEDTRONIC SOFAMOR DANEK, INC.

Bone-screw internal spinal fixation system, sterile

• Primary Device ID: 00643169783959
• NIH Device Record Key: e94096d3-4d16-4a41-b689-769bd60d66bb
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CD HORIZON® SOLERA® VOYAGER™ Spinal System
• Version Model Number: 55750018535
• Company DUNS: 830350380
• Company Name: MEDTRONIC SOFAMOR DANEK, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com

Device Dimensions

• Outer Diameter: 8.5 Millimeter
• Outer Diameter: 8.5 Millimeter
• Outer Diameter: 8.5 Millimeter
• Outer Diameter: 8.5 Millimeter
• Outer Diameter: 8.5 Millimeter
• Outer Diameter: 8.5 Millimeter
• Outer Diameter: 8.5 Millimeter
• Outer Diameter: 8.5 Millimeter
• Outer Diameter: 8.5 Millimeter
• Outer Diameter: 8.5 Millimeter
• Outer Diameter: 8.5 Millimeter
• Outer Diameter: 8.5 Millimeter
• Outer Diameter: 8.5 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00643169783959 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K170679

FDA Product Code

• NKB: Thoracolumbosacral pedicle screw system

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2018-02-03

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

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