FUSE ™ SPINAL SYSTEM

GUDID 00643169245600

DISTRACTOR 2870014 DISTRACTOR 14MM

MEDTRONIC SOFAMOR DANEK, INC.

Spinal implant trial

• Primary Device ID: 00643169245600
• NIH Device Record Key: 58c726e0-0e5f-4384-9f1c-9a01d533452e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: FUSE ™ SPINAL SYSTEM
• Version Model Number: 2870014
• 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: false
• 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

• Angle: 4 degree
• Angle: 4 degree
• Angle: 4 degree
• Angle: 4 degree

Device Identifiers

Device Issuing Agency	Device ID
GS1	00643169245600 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K121288

FDA Product Code

• MAX: Intervertebral fusion device with bone graft, lumbar

Sterilization

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

[00643169245600]

Moist Heat or Steam Sterilization

[00643169245600]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-02-07
• Device Publish Date: 2015-06-30

On-Brand Devices [FUSE ™ SPINAL SYSTEM]

• 00643169245723: DISTRACTOR 2870010 DISTRACTOR 10MM
• 00643169245716: DISTRACTOR 2870009 DISTRACTOR 9MM
• 00643169245693: INSERTER 2870006 FUSE INSERTER TUBE
• 00643169245662: INSERTER 2870001 FUSE INSERTER SHAFT
• 00643169245655: DISTRACTOR 2870011 DISTRACTOR 11MM
• 00643169245648: DISTRACTOR 2870012 DISTRACTOR 12MM
• 00643169245631: DISTRACTOR 2870013 DISTRACTOR 13MM
• 00643169245624: DISTRACTOR 2870007 DISTRACTOR 7MM
• 00643169245617: DISTRACTOR 2870008 DISTRACTOR 8MM
• 00643169245600: DISTRACTOR 2870014 DISTRACTOR 14MM
• 00643169245594: CAGE 2800724 FUSE 7MM X 24MM 0DEG
• 00643169245587: CAGE 2800824 FUSE 8MM X 24MM 0DEG
• 00643169245570: CAGE 2840924 FUSE 9MM X 24MM 4DEG
• 00643169245563: CAGE 2880924 FUSE 9MM X 24MM 8DEG
• 00643169245556: CAGE 2841024 FUSE 10MM X 24MM 4DEG
• 00643169245549: CAGE 2881024 FUSE 10MM X 24MM 8DEG
• 00643169245532: CAGE 2841124 FUSE 11MM X 24MM 4DEG
• 00643169245525: CAGE 2881124 FUSE 11MM X 24MM 8DEG
• 00643169245518: CAGE 2841224 FUSE 12MM X 24MM 4DEG
• 00643169245501: CAGE 2881224 FUSE 12MM X 24MM 8DEG
• 00643169245495: CAGE 2841324 FUSE 13MM X 24MM 4DEG
• 00643169245488: CAGE 2881324 FUSE 13MM X 24MM 8DEG
• 00643169245471: CAGE 2841424 FUSE 14MM X 24MM 4DEG
• 00643169245464: CAGE 2881424 FUSE 14MM X 24MM 8DEG