VANTAGE™ Anterior Fixation System

GUDID 00721902705403

SCREW 9330000 LOCK NUT TI

MEDTRONIC SOFAMOR DANEK, INC.

Metallic spinal fusion cage, non-sterile Metallic spinal fusion cage, non-sterile Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage

• Primary Device ID: 00721902705403
• NIH Device Record Key: 81df9369-d845-47e6-bc86-b486b4fecc58
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: VANTAGE™ Anterior Fixation System
• Version Model Number: 9330000
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00721902705403 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K023797

FDA Product Code

• KWP: APPLIANCE, FIXATION, SPINAL INTERLAMINAL

Sterilization

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

[00721902705403]

Moist Heat or Steam Sterilization

[00721902705403]

Moist Heat or Steam Sterilization

[00721902705403]

Moist Heat or Steam Sterilization

[00721902705403]

Moist Heat or Steam Sterilization

[00721902705403]

Moist Heat or Steam Sterilization

[00721902705403]

Moist Heat or Steam Sterilization

[00721902705403]

Moist Heat or Steam Sterilization

[00721902705403]

Moist Heat or Steam Sterilization

[00721902705403]

Moist Heat or Steam Sterilization

[00721902705403]

Moist Heat or Steam Sterilization

[00721902705403]

Moist Heat or Steam Sterilization

[00721902705403]

Moist Heat or Steam Sterilization

[00721902705403]

Moist Heat or Steam Sterilization

[00721902705403]

Moist Heat or Steam Sterilization

[00721902705403]

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 [VANTAGE™ Anterior Fixation System]

• 00613994704061: STAPLE X1009428 VAN TI THOR
• 00613994704054: STAPLE X1009427 VAN TI ATL
• 00613994184320: CASE 9339999 VANT SNGE BOLT OUTER CASE
• 00613994184313: CASE 9339998 VANT SNGL BOLT IMP TRAY LID
• 00613994184306: CASE 9339997 VANT SNGL BOLT IMP TRAY
• 00721902947933: PLATE 9331025 2.5CM THORACIC PLATE TI
• 00721902925641: PLATE 9331030 3CM THORACIC TI
• 00721902842450: BOLT 9338940 9.0X40MM TI
• 00721902842443: BOLT 9338935 9.0X35MM TI
• 00721902842436: BOLT 9338930 9.0X30MM TI
• 00721902842429: BOLT 9338925 9.0X25MM TI
• 00721902842412: BOLT 9338920 9.0X20MM TI
• 00721902842405: BOLT 9338040 8.0X40MM TI
• 00721902842399: BOLT 9338035 8.0X35MM TI
• 00721902842382: BOLT 9338030 8.0X30MM TI
• 00721902842375: BOLT 9338025 8.0X25MM TI
• 00721902842368: BOLT 9338020 8.0X20MM TI
• 00721902706653: PLATE 9330100 10CM ATL TI
• 00721902706646: PLATE 9330095 9 5CM ATL TI
• 00721902706639: PLATE 9330090 9CM ATL TI
• 00721902706622: PLATE 9330085 8 5CM ATL TI
• 00721902706615: PLATE 9330080 8CM ATL TI
• 00721902706608: PLATE 9330075 7 5CM ATL TI
• 00721902706592: PLATE 9330070 7CM ATL TI
• 00721902706585: PLATE 9330065 6 5CM ATL TI
• 00721902706578: PLATE 9330060 6CM ATL TI
• 00721902706561: PLATE 9330055 5 5CM ATL TI
• 00721902706554: PLATE 9330050 5CM ATL TI
• 00721902706547: PLATE 9330045 4 5CM ATL TI
• 00721902706530: PLATE 9330040 4CM ATL TI
• 00721902706509: PLATE 9331080 8CM THORACIC TI
• 00721902706479: PLATE 9331075 7.5CM THORACIC TI
• 00721902706462: PLATE 9331070 7CM THORACIC TI
• 00721902706448: PLATE 9331065 6 5CM THORACIC TI
• 00721902706301: PLATE 9331060 6CM THORACIC TI
• 00721902706196: PLATE 9331055 5 5CM THORACIC TI
• 00721902706172: PLATE 9331050 5CM THORACIC TI
• 00721902706141: PLATE 9331045 4.5CM THORACIC TI
• 00721902706134: PLATE 9331040 4CM THORACIC TI
• 00721902706110: PLATE 9331035 3 5CM THORACIC TI
• 00721902705618: SCREW 9336560 6.5X60MM SCREW ATL TI
• 00721902705601: SCREW 9336555 FAST ATL 6.5X55MM TI
• 00721902705595: SCREW 9336550 FAST ATL 6.5X50MM TI
• 00721902705588: SCREW 9336545 FAST ATL 6.5X45MM TI
• 00721902705571: SCREW 9336540 FAST ATL 6.5X40MM TI
• 00721902705564: SCREW 9336535 FAST ATL 6.5X35MM TI
• 00721902705540: SCREW 9336530 FAST ATL 6.5X30MM TI
• 00721902705533: SCREW 9336525 6.5X25MM SCREW ATL TI
• 00721902705526: SCREW 9335550 THORACIC 5.5X50MM TI
• 00721902705519: SCREW 9335545 THORACIC 5.5X45MM TI