DIVERGENCE™ ANTERIOR CERVICAL FUSION SYSTEM

GUDID 00643169515956

TRIAL 77307656 DIVERGE 0 DEG 5-6X17X16

MEDTRONIC SOFAMOR DANEK, INC.

Spinal implant trial

• Primary Device ID: 00643169515956
• NIH Device Record Key: d1274b6b-44f2-43ab-ba4f-643ffbe0cdf8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DIVERGENCE™ ANTERIOR CERVICAL FUSION SYSTEM
• Version Model Number: 77307656
• 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

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 Identifiers

Device Issuing Agency	Device ID
GS1	00643169515956 [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

[00643169515956]

Moist Heat or Steam Sterilization

[00643169515956]

Moist Heat or Steam Sterilization

[00643169515956]

Moist Heat or Steam Sterilization

[00643169515956]

Moist Heat or Steam Sterilization

[00643169515956]

Moist Heat or Steam Sterilization

[00643169515956]

Moist Heat or Steam Sterilization

[00643169515956]

Moist Heat or Steam Sterilization

[00643169515956]

Moist Heat or Steam Sterilization

[00643169515956]

Moist Heat or Steam Sterilization

[00643169515956]

Moist Heat or Steam Sterilization

[00643169515956]

Moist Heat or Steam Sterilization

[00643169515956]

Moist Heat or Steam Sterilization

[00643169515956]

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: 2016-07-08

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