DIVERGENCE™ ANTERIOR CERVICAL FUSION SYSTEM

GUDID 00643169516342

TRIAL 77365212 DIVERGE 6 DEG 11-12X15X12

MEDTRONIC SOFAMOR DANEK, INC.

Spinal implant trial Spinal implant trial Spinal implant trial Spinal implant trial Spinal implant trial Spinal implant trial Spinal implant trial Spinal implant trial Spinal implant trial Spinal implant trial Spinal implant trial Spinal implant trial Spinal implant trial Spinal implant trial Spinal implant trial Spinal implant trial Spinal implant trial

• Primary Device ID: 00643169516342
• NIH Device Record Key: e7361f13-bdf8-461b-a162-ee7235ebe305
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DIVERGENCE™ ANTERIOR CERVICAL FUSION SYSTEM
• Version Model Number: 77365212
• 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
• 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 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 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	00643169516342 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K142450

FDA Product Code

• ODP: Intervertebral fusion device with bone graft, cervical

Sterilization

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

[00643169516342]

Moist Heat or Steam Sterilization

[00643169516342]

Moist Heat or Steam Sterilization

[00643169516342]

Moist Heat or Steam Sterilization

[00643169516342]

Moist Heat or Steam Sterilization

[00643169516342]

Moist Heat or Steam Sterilization

[00643169516342]

Moist Heat or Steam Sterilization

[00643169516342]

Moist Heat or Steam Sterilization

[00643169516342]

Moist Heat or Steam Sterilization

[00643169516342]

Moist Heat or Steam Sterilization

[00643169516342]

Moist Heat or Steam Sterilization

[00643169516342]

Moist Heat or Steam Sterilization

[00643169516342]

Moist Heat or Steam Sterilization

[00643169516342]

Moist Heat or Steam Sterilization

[00643169516342]

Moist Heat or Steam Sterilization

[00643169516342]

Moist Heat or Steam Sterilization

[00643169516342]

Moist Heat or Steam Sterilization

[00643169516342]

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: 2015-08-18

On-Brand Devices [DIVERGENCE™ ANTERIOR CERVICAL FUSION SYSTEM]

• 00643169516397: TRIAL 77362612 DIVERGE 6 DEG 11-12X20X16
• 00643169516380: TRIAL 77362412 DIVERGE 6 DEG 11-12X20X14
• 00643169516373: TRIAL 77367612 DIVERGE 6 DEG 11-12X17X16
• 00643169516366: TRIAL 77367412 DIVERGE 6 DEG 11-12X17X14
• 00643169516359: TRIAL 77365412 DIVERGE 6 DEG 11-12X15X14
• 00643169516342: TRIAL 77365212 DIVERGE 6 DEG 11-12X15X12
• 00643169516335: TRIAL 77362690 DIVERGE 6 DEG 9-10X20X16
• 00643169516328: TRIAL 77362490 DIVERGE 6 DEG 9-10X20X14
• 00643169516311: TRIAL 77367690 DIVERGE 6 DEG 9-10X17X16
• 00643169516304: TRIAL 77367490 DIVERGE 6 DEG 9-10X17X14
• 00643169516298: TRIAL 77365490 DIVERGE 6 DEG 9-10X15X14
• 00643169516281: TRIAL 77365290 DIVERGE 6 DEG 9-10X15X12
• 00643169516274: TRIAL 77362678 DIVERGE 6 DEG 7-8X20X16
• 00643169516267: TRIAL 77362478 DIVERGE 6 DEG 7-8X20X14
• 00643169516250: TRIAL 77367678 DIVERGE 6 DEG 7-8X17X16
• 00643169516243: TRIAL 77367478 DIVERGE 6 DEG 7-8X17X14
• 00643169516236: TRIAL 77365478 DIVERGE 6 DEG 7-8X15X14
• 00643169516229: TRIAL 77365278 DIVERGE 6 DEG 7-8X15X12
• 00643169516212: TRIAL 77362656 DIVERGE 6 DEG 5-6X20X16
• 00643169516205: TRIAL 77362456 DIVERGE 6 DEG 5-6X20X14
• 00643169516199: TRIAL 77367656 DIVERGE 6 DEG 5-6X17X16
• 00643169516182: TRIAL 77367456 DIVERGE 6 DEG 5-6X17X14
• 00643169516175: TRIAL 77365456 DIVERGE 6 DEG 5-6X15X14
• 00643169516168: TRIAL 77365256 DIVERGE 6 DEG 5-6X15X12
• 00643169516151: TRIAL 77302612 DIVERGE 0 DEG 11-12X20X16
• 00643169516144: TRIAL 77302412 DIVERGE 0 DEG 11-12X20X14
• 00643169516137: TRIAL 77307612 DIVERGE 0 DEG 11-12X17X16
• 00643169516120: TRIAL 77307412 DIVERGE 0 DEG 11-12X17X14
• 00643169516113: TRIAL 77305412 DIVERGE 0 DEG 11-12X15X14
• 00643169516106: TRIAL 77305212 DIVERGE 0 DEG 11-12X15X12
• 00643169516090: TRIAL 77302690 DIVERGE 0 DEG 9-10X20X16
• 00643169516083: TRIAL 77302490 DIVERGE 0 DEG 9-10X20X14
• 00643169516076: TRIAL 77307690 DIVERGE 0 DEG 9-10X17X16
• 00643169516069: TRIAL 77307490 DIVERGE 0 DEG 9-10X17X14
• 00643169516052: TRIAL 77305490 DIVERGE 0 DEG 9-10X15X14
• 00643169516045: TRIAL 77305290 DIVERGE 0 DEG 9-10X15X12
• 00643169516038: TRIAL 77302678 DIVERGE 0 DEG 7-8X20X16
• 00643169516021: TRIAL 77302478 DIVERGE 0 DEG 7-8X20X14
• 00643169516014: TRIAL 77307678 DIVERGE 0 DEG 7-8X17X16
• 00643169516007: TRIAL 77307478 DIVERGE 0 DEG 7-8X17X14
• 00643169515994: TRIAL 77305478 DIVERGE 0 DEG 7-8X15X14
• 00643169515987: TRIAL 77305278 DIVERGE 0 DEG 7-8X15X12
• 00643169515970: TRIAL 77302656 DIVERGE 0 DEG 5-6X20X16
• 00643169515963: TRIAL 77302456 DIVERGE 0 DEG 5-6X20X14
• 00643169515956: TRIAL 77307656 DIVERGE 0 DEG 5-6X17X16
• 00643169515949: TRIAL 77307456 DIVERGE 0 DEG 5-6X17X14
• 00643169515932: TRIAL 77305456 DIVERGE 0 DEG 5-6X15X14
• 00643169515925: TRIAL 77305256 DIVERGE 0 DEG 5-6X15X12
• 00643169362895: INSERTER 6620810 FREEHND INSRTER SLEEVE
• 00643169362888: GUIDE 7730812 MINI-PLATE 12MM GUIDE