CD® Spinal System

GUDID 00721902575372

SCREW 8655750 CDH 5.5 TULIP 7MMX50MM ASY

MEDTRONIC SOFAMOR DANEK, INC.

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

• Primary Device ID: 00721902575372
• NIH Device Record Key: 6ac26221-9227-4cfb-9470-5c07885ef5dc
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CD® Spinal System
• Version Model Number: 8655750
• 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

Device Dimensions

• Outer Diameter: 7 Millimeter
• Outer Diameter: 7 Millimeter
• Outer Diameter: 7 Millimeter
• Outer Diameter: 7 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00721902575372 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K000476

FDA Product Code

• MNH: Orthosis, spondylolisthesis spinal fixation

Sterilization

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

[00721902575372]

Moist Heat or Steam Sterilization

[00721902575372]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2015-07-31

On-Brand Devices [CD® Spinal System]

• 00721902575372: SCREW 8655750 CDH 5.5 TULIP 7MMX50MM ASY
• 00721902575358: SCREW 8655745 CDH 5.5 TULIP 7MMX45MM ASY
• 00721902575341: SCREW 8655740 CDH 5.5 TULIP 7MMX40MM ASY
• 00721902575334: SCREW 8655645 CDH 5.5 TULIP 6MMX45MM ASY
• 00721902575327: SCREW 8655640 CDH 5.5 TULIP 6MMX40MM ASY
• 00721902575280: SCREW 8655635 CDH 5.5 TULIP 6MMX35MM ASY
• 00721902575273: SCREW 8655545 CDH 5.5 TULIP 5MMX45MM ASY
• 00721902575259: SCREW 8655540 CDH 5.5 TULIP 5MMX40MM ASY
• 00721902575242: SCREW 8655535 CDH 5.5 TULIP 5MMX35MM ASY