CD HORIZON ESSENCE™ Spinal System

GUDID 00643169428898

SET SCREW 4540020 ESSENCE BREAK-OFF

MEDTRONIC SOFAMOR DANEK, INC.

Bone-screw internal spinal fixation system, non-sterile

• Primary Device ID: 00643169428898
• NIH Device Record Key: 0ea3fcce-f1c4-4f96-9341-98ee0e7ff6f9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CD HORIZON ESSENCE™ Spinal System
• Version Model Number: 4540020
• 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
• 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 Identifiers

Device Issuing Agency	Device ID
GS1	00643169428898 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K142591

FDA Product Code

• KWP: APPLIANCE, FIXATION, SPINAL INTERLAMINAL

Sterilization

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

[00643169428898]

Moist Heat or Steam Sterilization

[00643169428898]

Moist Heat or Steam Sterilization

[00643169428898]

Moist Heat or Steam Sterilization

[00643169428898]

Moist Heat or Steam Sterilization

[00643169428898]

Moist Heat or Steam Sterilization

[00643169428898]

Moist Heat or Steam Sterilization

[00643169428898]

Moist Heat or Steam Sterilization

[00643169428898]

Moist Heat or Steam Sterilization

[00643169428898]

Moist Heat or Steam Sterilization

[00643169428898]

Moist Heat or Steam Sterilization

[00643169428898]

Moist Heat or Steam Sterilization

[00643169428898]

Moist Heat or Steam Sterilization

[00643169428898]

Moist Heat or Steam Sterilization

[00643169428898]

Moist Heat or Steam Sterilization

[00643169428898]

Moist Heat or Steam Sterilization

[00643169428898]

Moist Heat or Steam Sterilization

[00643169428898]

Moist Heat or Steam Sterilization

[00643169428898]

Moist Heat or Steam Sterilization

[00643169428898]

Moist Heat or Steam Sterilization

[00643169428898]

Moist Heat or Steam Sterilization

[00643169428898]

Moist Heat or Steam Sterilization

[00643169428898]

Moist Heat or Steam Sterilization

[00643169428898]

Moist Heat or Steam Sterilization

[00643169428898]

Moist Heat or Steam Sterilization

[00643169428898]

Moist Heat or Steam Sterilization

[00643169428898]

Moist Heat or Steam Sterilization

[00643169428898]

Moist Heat or Steam Sterilization

[00643169428898]

Moist Heat or Steam Sterilization

[00643169428898]

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: 2018-01-27

On-Brand Devices [CD HORIZON ESSENCE™ Spinal System]

• 00643169428898: SET SCREW 4540020 ESSENCE BREAK-OFF
• 00643169428812: SCREW 45440004540 ESSENCE MAS 4.5X40
• 00643169428775: SCREW 45440005540 ESSENCE MAS 5.5X40
• 00643169428751: SCREW 45440005550 ESSENCE MAS 5.5X50
• 00643169428720: SCREW 45440006540 ESSENCE MAS 6.5X40
• 00643169428676: SCREW 45440007540 ESSENCE MAS 7.5X40
• 00643169428645: SCREW 45440008560 ESSENCE MAS 8.5X60
• 00643169428560: SCREW 45410005540 ESSENCE FAS 5.5X40
• 00643169428836: SCREW 45440004520 ESSENCE MAS 4.5X20
• 00763000802134: SET SCREW 4540020 ESSENCE BREAK-OFF
• 00763000794682: SCREW 45440004520 ESSENCE MAS 4.5X20
• 00763000794668: SCREW 45440004540 ESSENCE MAS 4.5X40
• 00763000794620: SCREW 45440005540 ESSENCE MAS 5.5X40
• 00763000794606: SCREW 45440005550 ESSENCE MAS 5.5X50
• 00763000794576: SCREW 45440006540 ESSENCE MAS 6.5X40
• 00763000794521: SCREW 45440007540 ESSENCE MAS 7.5X40
• 00763000794491: SCREW 45440008560 ESSENCE MAS 8.5X60