XANTUS® Anterior Lateral Supplemental Fixation System

GUDID 00721902225345

FIXE ANGLE LOCKING PLATE 48MM

MEDTRONIC SOFAMOR DANEK, INC.

Bone-screw internal spinal fixation system, non-sterile

• Primary Device ID: 00721902225345
• NIH Device Record Key: 36f945f6-a90b-4f6e-9d8a-07fa8fdeecbb
• Commercial Distribution Discontinuation: 2018-10-08
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: XANTUS® Anterior Lateral Supplemental Fixation System
• Version Model Number: 8967448
• 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

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 Identifiers

Device Issuing Agency	Device ID
GS1	00721902225345 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K022070

FDA Product Code

• KWP: APPLIANCE, FIXATION, SPINAL INTERLAMINAL

Sterilization

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

[00721902225345]

Moist Heat or Steam Sterilization

[00721902225345]

Moist Heat or Steam Sterilization

[00721902225345]

Moist Heat or Steam Sterilization

[00721902225345]

Moist Heat or Steam Sterilization

[00721902225345]

Moist Heat or Steam Sterilization

[00721902225345]

Moist Heat or Steam Sterilization

[00721902225345]

Moist Heat or Steam Sterilization

[00721902225345]

Moist Heat or Steam Sterilization

[00721902225345]

Moist Heat or Steam Sterilization

[00721902225345]

Moist Heat or Steam Sterilization

[00721902225345]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-01-25
• Device Publish Date: 2015-07-30

On-Brand Devices [XANTUS® Anterior Lateral Supplemental Fixation System]

• 00721902227394: FIXE ANGLE LOCKING PLATE 60MM
• 00721902226786: FIXE ANGLE LOCKING PLATE 56MM
• 00721902225796: FIXE ANGLE LOCKING PLATE 52MM
• 00721902225345: FIXE ANGLE LOCKING PLATE 48MM
• 00721902225000: FIXE ANGLE LOCKING PLATE 44MM
• 00721902224058: PLATE 8967260 COVER PLATE 60MM
• 00721902222962: PLATE 8967256 COVER PLATE 56MM
• 00721902222283: PLATE 8967252 COVER PLATE 52MM
• 00721902221927: PLATE 8967248 COVER PLATE 48MM
• 00721902219535: PLATE 8967244 COVER PLATE 44MM
• 00721902216077: PLATE 8967160 PLATE 60MM
• 00721902215704: PLATE 8967156 PLATE 56MM
• 00721902215261: PLATE 8967152 PLATE 52MM
• 00721902214707: PLATE 8967148 PLATE 48MM
• 00721902214691: PLATE 8967144 PLATE 44MM