CD HORIZON® Fenestrated Screw Set

GUDID 00763000143756

FNS SAS 55851025545 CCM 5.5 X 45

MEDTRONIC SOFAMOR DANEK, INC.

Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile

• Primary Device ID: 00763000143756
• NIH Device Record Key: dd430dea-d6f6-4c8e-b898-02f275447e9a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CD HORIZON® Fenestrated Screw Set
• Version Model Number: 55851025545
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00763000143756 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K201362

FDA Product Code

• NKB: Thoracolumbosacral pedicle screw system

Sterilization

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

[00763000143756]

Moist Heat or Steam Sterilization

[00763000143756]

Moist Heat or Steam Sterilization

[00763000143756]

Moist Heat or Steam Sterilization

[00763000143756]

Moist Heat or Steam Sterilization

[00763000143756]

Moist Heat or Steam Sterilization

[00763000143756]

Moist Heat or Steam Sterilization

[00763000143756]

Moist Heat or Steam Sterilization

[00763000143756]

Moist Heat or Steam Sterilization

[00763000143756]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-10-26
• Device Publish Date: 2020-10-16

On-Brand Devices [CD HORIZON® Fenestrated Screw Set]

• 00643169679429: DRIVER 7480755T 5.5/6.0 MAS LOCK SLEEVE
• 00643169679412: DRIVER 7480745T 4.75 MAS LOCK SLEEVE
• 00643169679405: SHAFT 7480741T ADAPTER DRIVER QC SHAFT
• 00643169679320: MAS 55840021580T 5.5/6.0 FNSTRTD 10.5X80
• 00643169679313: MAS 55840021575T 5.5/6.0 FNSTRTD 10.5X75
• 00643169679306: MAS 55840021570T 5.5/6.0 FNSTRTD 10.5X70
• 00643169679290: MAS 55840021565T 5.5/6.0 FNSTRTD 10.5X65
• 00643169679283: MAS 55840021560T 5.5/6.0 FNSTRTD 10.5X60
• 00643169679276: MAS 55840021555T 5.5/6.0 FNSTRTD 10.5X55
• 00643169679269: MAS 55840021550T 5.5/6.0 FNSTRTD 10.5X50
• 00643169679252: MAS 55840021545T 5.5/6.0 FNSTRTD 10.5X45
• 00643169679245: MAS 55840021540T 5.5/6.0 FNSTRTD 10.5X40
• 00643169679238: MAS 55840029580T 5.5/6.0 FENSTRTD 9.5X80
• 00643169679221: MAS 55840029575T 5.5/6.0 FENSTRTD 9.5X75
• 00643169679214: MAS 55840029570T 5.5/6.0 FENSTRTD 9.5X70
• 00643169679207: MAS 55840029565T 5.5/6.0 FENSTRTD 9.5X65
• 00643169679191: MAS 55840029560T 5.5/6.0 FENSTRTD 9.5X60
• 00643169679184: MAS 55840029555T 5.5/6.0 FENSTRTD 9.5X55
• 00643169679177: MAS 55840029550T 5.5/6.0 FENSTRTD 9.5X50
• 00643169679160: MAS 55840029545T 5.5/6.0 FENSTRTD 9.5X45
• 00643169679153: MAS 55840029540T 5.5/6.0 FENSTRTD 9.5X40
• 00643169679146: MAS 55840029535T 5.5/6.0 FENSTRTD 9.5X35
• 00643169679139: MAS 55840029530T 5.5/6.0 FENSTRTD 9.5X30
• 00643169679122: MAS 55840028580T 5.5/6.0 FENSTRTD 8.5X80
• 00643169679115: MAS 55840028575T 5.5/6.0 FENSTRTD 8.5X75
• 00643169679108: MAS 55840028570T 5.5/6.0 FENSTRTD 8.5X70
• 00643169679092: MAS 55840028565T 5.5/6.0 FENSTRTD 8.5X65
• 00643169679085: MAS 55840028560T 5.5/6.0 FENSTRTD 8.5X60
• 00643169679078: MAS 55840028555T 5.5/6.0 FENSTRTD 8.5X55
• 00643169679061: MAS 55840028550T 5.5/6.0 FENSTRTD 8.5X50
• 00643169679054: MAS 55840028545T 5.5/6.0 FENSTRTD 8.5X45
• 00643169679047: MAS 55840028540T 5.5/6.0 FENSTRTD 8.5X40
• 00643169679030: MAS 55840028535T 5.5/6.0 FENSTRTD 8.5X35
• 00643169679023: MAS 55840028530T 5.5/6.0 FENSTRTD 8.5X30
• 00643169679016: MAS 55840027580T 5.5/6.0 FENSTRTD 7.5X80
• 00643169679009: MAS 55840027575T 5.5/6.0 FENSTRTD 7.5X75
• 00643169678996: MAS 55840027570T 5.5/6.0 FENSTRTD 7.5X70
• 00643169678989: MAS 55840027565T 5.5/6.0 FENSTRTD 7.5X65
• 00643169678972: MAS 55840027560T 5.5/6.0 FENSTRTD 7.5X60
• 00643169678965: MAS 55840027555T 5.5/6.0 FENSTRTD 7.5X55
• 00643169678958: MAS 55840027550T 5.5/6.0 FENSTRTD 7.5X50
• 00643169678941: MAS 55840027545T 5.5/6.0 FENSTRTD 7.5X45
• 00643169678934: MAS 55840027540T 5.5/6.0 FENSTRTD 7.5X40
• 00643169678927: MAS 55840027535T 5.5/6.0 FENSTRTD 7.5X35
• 00643169678910: MAS 55840027530T 5.5/6.0 FENSTRTD 7.5X30
• 00643169678903: MAS 55840026580T 5.5/6.0 FENSTRTD 6.5X80
• 00643169678897: MAS 55840026575T 5.5/6.0 FENSTRTD 6.5X75
• 00643169678880: MAS 55840026570T 5.5/6.0 FENSTRTD 6.5X70
• 00643169678873: MAS 55840026565T 5.5/6.0 FENSTRTD 6.5X65
• 00643169678866: MAS 55840026560T 5.5/6.0 FENSTRTD 6.5X60