Clydesdale™ Spinal System

GUDID 00613994973795

TRIAL 2987440 22MM 0 DEG 14 X 40 DL

MEDTRONIC SOFAMOR DANEK, INC.

Spinal implant trial

• Primary Device ID: 00613994973795
• NIH Device Record Key: d8534217-c01f-4042-a70e-fee0bc9ed2d2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Clydesdale™ Spinal System
• Version Model Number: 2987440
• 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: false
• 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
• 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: 14 Millimeter
• Outer Diameter: 14 Millimeter
• Outer Diameter: 14 Millimeter
• Outer Diameter: 14 Millimeter
• Outer Diameter: 14 Millimeter
• Outer Diameter: 14 Millimeter
• Length: 40 Millimeter
• Angle: 0 degree
• Outer Diameter: 14 Millimeter
• Length: 40 Millimeter
• Angle: 0 degree
• Outer Diameter: 14 Millimeter
• Length: 40 Millimeter
• Angle: 0 degree
• Outer Diameter: 14 Millimeter
• Length: 40 Millimeter
• Angle: 0 degree
• Outer Diameter: 14 Millimeter
• Length: 40 Millimeter
• Angle: 0 degree
• Outer Diameter: 14 Millimeter
• Length: 40 Millimeter
• Angle: 0 degree
• Outer Diameter: 14 Millimeter
• Length: 40 Millimeter
• Angle: 0 degree
• Outer Diameter: 14 Millimeter
• Length: 40 Millimeter
• Angle: 0 degree
• Outer Diameter: 14 Millimeter
• Length: 40 Millimeter
• Angle: 0 degree
• Outer Diameter: 14 Millimeter
• Length: 40 Millimeter
• Angle: 0 degree
• Outer Diameter: 14 Millimeter
• Length: 40 Millimeter
• Angle: 0 degree
• Outer Diameter: 14 Millimeter
• Length: 40 Millimeter
• Angle: 0 degree
• Outer Diameter: 14 Millimeter
• Length: 40 Millimeter
• Angle: 0 degree
• Outer Diameter: 14 Millimeter
• Length: 40 Millimeter
• Angle: 0 degree
• Outer Diameter: 14 Millimeter
• Length: 40 Millimeter
• Angle: 0 degree
• Outer Diameter: 14 Millimeter
• Length: 40 Millimeter
• Angle: 0 degree
• Outer Diameter: 14 Millimeter
• Length: 40 Millimeter
• Angle: 0 degree
• Outer Diameter: 14 Millimeter
• Length: 40 Millimeter
• Angle: 0 degree
• Outer Diameter: 14 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00613994973795 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K113528

FDA Product Code

• MAX: Intervertebral fusion device with bone graft, lumbar

Sterilization

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

[00613994973795]

Moist Heat or Steam Sterilization

[00613994973795]

Moist Heat or Steam Sterilization

[00613994973795]

Moist Heat or Steam Sterilization

[00613994973795]

Moist Heat or Steam Sterilization

[00613994973795]

Moist Heat or Steam Sterilization

[00613994973795]

Moist Heat or Steam Sterilization

[00613994973795]

Moist Heat or Steam Sterilization

[00613994973795]

Moist Heat or Steam Sterilization

[00613994973795]

Moist Heat or Steam Sterilization

[00613994973795]

Moist Heat or Steam Sterilization

[00613994973795]

Moist Heat or Steam Sterilization

[00613994973795]

Moist Heat or Steam Sterilization

[00613994973795]

Moist Heat or Steam Sterilization

[00613994973795]

Moist Heat or Steam Sterilization

[00613994973795]

Moist Heat or Steam Sterilization

[00613994973795]

Moist Heat or Steam Sterilization

[00613994973795]

Moist Heat or Steam Sterilization

[00613994973795]

Moist Heat or Steam Sterilization

[00613994973795]

Moist Heat or Steam Sterilization

[00613994973795]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-02-07
• Device Publish Date: 2015-09-10

On-Brand Devices [Clydesdale™ Spinal System]

• 00613994866523: INSERTER 2942001 DL INSERTER
• 00613994725653: TRIAL X1209240 8X40 0 DEG LORDOSIS MOD
• 00613994725646: TRIAL X1209245 8X45 0 DEG LORDOSIS MOD
• 00613994725639: TRIAL X1209250 8X50 0 DEG LORDOSIS MOD
• 00613994725622: TRIAL X1209255 8X55 0 DEG LORDOSIS MOD
• 00613994725615: TRIAL X1209340 10X40 0 DEG LORDOSIS MOD
• 00613994725608: TRIAL X1209345 10X45 0 DEG LORDOSIS MOD
• 00613994725592: TRIAL X1209350 10X50 0 DEG LORDOSIS MOD
• 00613994725585: TRIAL X1209355 10X55 0 DEG LORDOSIS MOD
• 00613994725578: TRIAL X1209440 12X40 0 DEG LORDOSIS MOD
• 00613994725561: TRIAL X1209445 12X45 0 DEG LORDOSIS MOD
• 00613994725554: TRIAL X1209450 12X50 0 DEG LORDOSIS MOD
• 00613994725547: TRIAL X1209455 12X55 0 DEG LORDOSIS MOD
• 00613994725530: TRIAL X1209540 14X40 0 DEG LORDOSIS MOD
• 00613994725523: TRIAL X1209545 14X45 0 DEG LORDOSIS MOD
• 00613994725516: TRIAL X1209550 14X50 0 DEG LORDOSIS MOD
• 00613994725509: TRIAL X1209555 14X55 0 DEG LORDOSIS MOD
• 00613994725493: TRIAL X1209640 16X40 0 DEG LORDOSIS MOD
• 00613994725486: TRIAL X1209645 16X45 0 DEG LORDOSIS MOD
• 00613994725479: TRIAL X1209650 16X50 0 DEG LORDOSIS MOD
• 00613994725462: TRIAL X1209655 16X55 0 DEG LORDOSIS MOD
• 00613994724571: HANDLE X1209145 TRIAL MODULAR
• 00613994711427: DISTRACTOR X1009437 CLYDES 12 DEG 8X45
• 00613994711410: DISTRACTOR X1009438 CLYDES 12 DEG 8X50
• 00613994711403: DISTRACTOR X1009439 CLYDES 12 DEG 8X55
• 00613994711397: DISTRACTOR X1009440 CLYDES 12 DEG 10X45
• 00613994711380: DISTRACTOR X1009441 CLYDES 12 DEG 10X50
• 00613994711373: DISTRACTOR X1009442 CLYDES 12 DEG 10X55
• 00613994711366: DISTRACTOR X1009443 CLYDES 12 DEG 12X45
• 00613994711359: DISTRACTOR X1009444 CLYDES 12 DEG 12X50
• 00613994711342: DISTRACTOR X1009445 CLYDES 12 DEG 12X55
• 00613994711335: DISTRACTOR X1009446 CLYDES 12 DEG 14X45
• 00613994711328: DISTRACTOR X1009447 CLYDES 12 DEG 14X50
• 00613994711311: DISTRACTOR X1009448 CLYDES 12 DEG 14X55
• 00613994706119: INSTRUMENT X0909751 CLYDE 22W 8X45 TRIAL
• 00613994706102: INSTRUMENT X0909752 CLYDE 22W 8X50 TRIAL
• 00613994706096: INSTRUMENT X0909753 CLYDE 22W 8X55 TRIAL
• 00613994706089: INSTRUMENT X0909754 CLYDE 22W 10X45 TRL
• 00613994706072: INSTRUMENT X0909755 CLYDE 22W 10X50 TRL
• 00613994706065: INSTRUMENT X0909756 CLYDE 22W 10X55 TRL
• 00613994706058: INSTRUMENT X0909757 CLYDE 22W 12X45 TRL
• 00613994706041: INSTRUMENT X0909758 CLYDE 22W 12X50 TRL
• 00613994706034: INSTRUMENT X0909759 CLYDE 22W 12X55 TRL
• 00613994706027: INSTRUMENT X0909760 CLYDE 22W 14X45 TRL
• 00613994706010: INSTRUMENT X0909761 CLYDE 22W 14X50 TRL
• 00613994706003: INSTRUMENT X0909762 CLYDE 22W 14X55 TRL
• 00613994705006: CAGE X0909600 CLYDESDALE PK IB 12 8X45
• 00613994704993: CAGE X0909601 CLYDESDALE PK IB 12 10X45
• 00613994704986: CAGE X0909602 CLYDESDALE PK IB 12 12X45
• 00613994704979: CAGE X0909603 CLYDESDALE PK IB 12 14X45