AXIS® Fixation System

GUDID 00721902815522

AXIS SCR-TI-CANC-W/HOLE-3.5X14

MEDTRONIC SOFAMOR DANEK, INC.

Bone-screw internal spinal fixation system, non-sterile

• Primary Device ID: 00721902815522
• NIH Device Record Key: 599f8fbc-d80b-46e1-9ab9-bc528d240f6d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AXIS® Fixation System
• Version Model Number: X8700214
• 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

Device Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	00721902815522 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K924085

FDA Product Code

• HRS: PLATE, FIXATION, BONE

Sterilization

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

[00721902815522]

Moist Heat or Steam Sterilization

[00721902815522]

Moist Heat or Steam Sterilization

[00721902815522]

Moist Heat or Steam Sterilization

[00721902815522]

Moist Heat or Steam Sterilization

[00721902815522]

Moist Heat or Steam Sterilization

[00721902815522]

Moist Heat or Steam Sterilization

[00721902815522]

Moist Heat or Steam Sterilization

[00721902815522]

Moist Heat or Steam Sterilization

[00721902815522]

Moist Heat or Steam Sterilization

[00721902815522]

Moist Heat or Steam Sterilization

[00721902815522]

Moist Heat or Steam Sterilization

[00721902815522]

Moist Heat or Steam Sterilization

[00721902815522]

Moist Heat or Steam Sterilization

[00721902815522]

Moist Heat or Steam Sterilization

[00721902815522]

Moist Heat or Steam Sterilization

[00721902815522]

Moist Heat or Steam Sterilization

[00721902815522]

Moist Heat or Steam Sterilization

[00721902815522]

Moist Heat or Steam Sterilization

[00721902815522]

Moist Heat or Steam Sterilization

[00721902815522]

Moist Heat or Steam Sterilization

[00721902815522]

Moist Heat or Steam Sterilization

[00721902815522]

Moist Heat or Steam Sterilization

[00721902815522]

Moist Heat or Steam Sterilization

[00721902815522]

Moist Heat or Steam Sterilization

[00721902815522]

Moist Heat or Steam Sterilization

[00721902815522]

Moist Heat or Steam Sterilization

[00721902815522]

Moist Heat or Steam Sterilization

[00721902815522]

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: 2015-08-19

On-Brand Devices [AXIS® Fixation System]

• 00721902815522: AXIS SCR-TI-CANC-W/HOLE-3.5X14
• 00885074525884: BONE SCREW
• 00673978994673: AXIS SHORT L PLATE TEMPLATE