AFFINITY® Anterior Cervical Cage System

GUDID 00721902307850

CAGE 6390411 AFFINITY CERV 11MM X 14MM

MEDTRONIC SOFAMOR DANEK, INC.

Metallic spinal interbody fusion cage

• Primary Device ID: 00721902307850
• NIH Device Record Key: eb31bf7e-c821-44d3-9cb5-f6a67d71f5f5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AFFINITY® Anterior Cervical Cage System
• Version Model Number: 6390411
• 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

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00721902307850 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P000028

FDA Product Code

• MAX: Intervertebral fusion device with bone graft, lumbar

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2020-02-24
• Device Publish Date: 2016-04-07

On-Brand Devices [AFFINITY® Anterior Cervical Cage System]

• 00721902307867: AFFINITY CERV CAGE 12MM X 14MM
• 00721902307850: CAGE 6390411 AFFINITY CERV 11MM X 14MM
• 00721902307843: CAGE 6390410 AFFINITY CRV 10MM X 14MM
• 00721902307836: CAGE 6390409 AFFINITY CRV 9MM X 14MM
• 00721902307829: CAGE 6390408 AFFINITY CRV 8MM X 14MM
• 00721902307805: CAGE 6390407 AFFINITY CRV 7MM X 14MM
• 00721902307782: CAGE 6390406 AFFINITY CRV 6MM X 14MM
• 00721902307775: AFFINITY CERV CAGE 12MM X 12MM
• 00721902307737: CAGE 6390211 AFFINITY CRV 11MM X 12MM
• 00721902307713: CAGE 6390210 AFFINITY CRV 10MM X 12MM
• 00721902307706: CAGE 6390209 AFFINITY CRV 9MM X 12MM
• 00721902307690: CAGE 6390208 AFFINITY CRV 8MM X 12MM
• 00721902307676: CAGE 6390207 AFFINITY CRV 7MM X 12MM
• 00721902307652: CAGE 6390206 AFFINITY CERV CAGE 6MMX12MM