ANATOMIC PEEK CERVICAL FUSION SYSTEM

GUDID 00613994360519

IMPLANT 4240886 ANATOMIC C 18X16X 8MM

MEDTRONIC SOFAMOR DANEK, INC.

Metallic spinal interbody fusion cage

• Primary Device ID: 00613994360519
• NIH Device Record Key: 0e972e5b-cc03-4325-9743-e759c99bffed
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ANATOMIC PEEK CERVICAL FUSION SYSTEM
• Version Model Number: 4240886
• 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

• Width: 18 Millimeter
• Width: 18 Millimeter
• Width: 18 Millimeter
• Width: 18 Millimeter
• Width: 18 Millimeter
• Width: 18 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00613994360519 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K112444

FDA Product Code

• ODP: Intervertebral fusion device with bone graft, cervical

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: 2015-07-08

On-Brand Devices [ANATOMIC PEEK CERVICAL FUSION SYSTEM]

• 00613994366474: IMPLANT 4240564 ANATOMIC C 16X14X 5MM
• 00613994366467: IMPLANT 4240664 ANATOMIC C 16X14X 6MM
• 00613994366450: IMPLANT 4240764 ANATOMIC C 16X14X 7MM
• 00613994366443: IMPLANT 4240864 ANATOMIC C 16X14X 8MM
• 00613994366436: IMPLANT 4240964 ANATOMIC C 16X14X 9MM
• 00613994366429: IMPLANT 4240064 ANATOMIC C 16X14X 10MM
• 00613994366412: IMPLANT 4240164 ANATOMIC C 16X14X 11MM
• 00613994366405: IMPLANT 4240264 ANATOMIC C 16X14X 12MM
• 00613994366399: IMPLANT 4240364 ANATOMIC C 16X14X 13MM
• 00613994366382: IMPLANT 4240464 ANATOMIC C 16X14X 14MM
• 00613994360656: IMPLANT 4240541 ANATOMIC C 14X11X 5MM
• 00613994360649: IMPLANT 4240641 ANATOMIC C 14X11X 6MM
• 00613994360632: IMPLANT 4240741 ANATOMIC C 14X11X 7MM
• 00613994360625: IMPLANT 4240841 ANATOMIC C 14X11X 8MM
• 00613994360618: IMPLANT 4240941 ANATOMIC C 14X11X 9MM
• 00613994360601: IMPLANT 4240041 ANATOMIC C 14X11X 10MM
• 00613994360595: IMPLANT 4240141 ANATOMIC C 14X11X 11MM
• 00613994360588: IMPLANT 4240241 ANATOMIC C 14X11X 12MM
• 00613994360571: IMPLANT 4240341 ANATOMIC C 14X11X 13MM
• 00613994360564: IMPLANT 4240441 ANATOMIC C 14X11X 14MM
• 00613994360540: IMPLANT 4240586 ANATOMIC C 18X16X 5MM
• 00613994360533: IMPLANT 4240686 ANATOMIC C 18X16X 6MM
• 00613994360526: IMPLANT 4240786 ANATOMIC C 18X16X 7MM
• 00613994360519: IMPLANT 4240886 ANATOMIC C 18X16X 8MM
• 00613994360502: IMPLANT 4240986 ANATOMIC C 18X16X 9MM
• 00613994360496: IMPLANT 4240086 ANATOMIC C 18X16X 10MM
• 00613994360489: IMPLANT 4240186 ANATOMIC C 18X16X 11MM
• 00613994360472: IMPLANT 4240286 ANATOMIC C 18X16X 12MM
• 00613994360465: IMPLANT 4240386 ANATOMIC C 18X16X 13MM
• 00613994360458: IMPLANT 4240486 ANATOMIC C 18X16X 14MM