Divergence® Anterior Cervical Fusion System

GUDID 00643169337596

IMPLANT G6626742 NP LORDO 12MMX17MMX14MM

MEDTRONIC SOFAMOR DANEK, INC.

Polymeric spinal fusion cage, sterile

• Primary Device ID: 00643169337596
• NIH Device Record Key: cc2e3eb3-1fb8-471c-bae3-dabd26f73b9a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Divergence® Anterior Cervical Fusion System
• Version Model Number: G6626742
• 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
• 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

• Depth: 14 Millimeter
• Depth: 14 Millimeter
• Depth: 14 Millimeter
• Depth: 14 Millimeter
• Depth: 14 Millimeter
• Depth: 14 Millimeter
• Depth: 14 Millimeter
• Depth: 14 Millimeter
• Height: 12 Millimeter
• Width: 17 Millimeter
• Angle: 6 degree
• Depth: 14 Millimeter
• Height: 12 Millimeter
• Width: 17 Millimeter
• Angle: 6 degree
• Depth: 14 Millimeter
• Height: 12 Millimeter
• Width: 17 Millimeter
• Angle: 6 degree
• Depth: 14 Millimeter
• Height: 12 Millimeter
• Width: 17 Millimeter
• Angle: 6 degree
• Depth: 14 Millimeter
• Height: 12 Millimeter
• Width: 17 Millimeter
• Angle: 6 degree
• Depth: 14 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00643169337596 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K141599

FDA Product Code

• OVE: Intervertebral fusion device with integrated fixation, 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: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2015-10-02

On-Brand Devices [Divergence® Anterior Cervical Fusion System]

• 00643169443259: SPACER G7736766 MP LORDO 6MMX17MMX16MM
• 00643169363458: KNOB 6630909 INSERTER KNOB
• 00643169363182: GUIDE 6628152 NO-P 12MM X 15MM GUIDE
• 00643169363175: GUIDE 6628171 NO-P 11MM X 17MM GUIDE
• 00643169363168: GUIDE 6628151 NO-P 11MM X 15MM GUIDE
• 00643169363151: GUIDE 6628170 NO-P 10MM X 17MM GUIDE
• 00643169363144: GUIDE 6628150 NO-P 10MM X 15MM GUIDE
• 00643169363137: GUIDE 6628179 NO-P 9MM X 17MM GUIDE
• 00643169363120: GUIDE 6628159 NO-P 9MM X 15MM GUIDE
• 00643169363113: GUIDE 6628178 NO-P 8MM X 17MM GUIDE
• 00643169363106: GUIDE 6628158 NO-P 8MM X 15MM GUIDE
• 00643169363090: GUIDE 6628177 NO-P 7MM X 17MM GUIDE
• 00643169363083: GUIDE 6628157 NO-P 7MM X 15MM GUIDE
• 00643169363076: GUIDE 6628176 NO-P 6MM X 17MM GUIDE
• 00643169363069: GUIDE 6628156 NO-P 6MM X 15MM GUIDE
• 00643169363052: GUIDE 6628175 NO-P 5MM X 17MM GUIDE
• 00643169363045: GUIDE 6628155 NO-P 5MM X 15MM GUIDE
• 00643169363038: GUIDE 6620800 NO-P GUIDE SLEEVE
• 00643169363021: GUIDE 6628172 NO-P 12MM X 17MM GUIDE
• 00643169363014: GUIDE 7730800 MINI-PLATE GUIDE SHAFT
• 00643169363007: GUIDE 7730805 MINI-PLATE 5MM GUIDE
• 00643169362994: GUIDE 7730806 MINI-PLATE 6MM GUIDE
• 00643169362987: GUIDE 7730807 MINI-PLATE 7MM GUIDE
• 00643169362970: GUIDE 7730808 MINI-PLATE 8MM GUIDE
• 00643169362963: GUIDE 7730809 MINI-PLATE 9MM GUIDE
• 00643169362956: GUIDE 7730810 MINI-PLATE 10MM GUIDE
• 00643169362949: INSERTER 7730816 MP FREEHND INSRTR IB
• 00643169362932: INSERTER 7730815 MP FREEHND INSRTR PLT
• 00643169362925: INSERTER 7730814 MP FREEHND INSRTR PLTIB
• 00643169362918: INSERTER 6620812 NO-P FREEHND INSRTR 17
• 00643169362901: INSERTER 6620811 NO-P FREEHND INSRTR 15
• 00643169362826: TRIAL 66265256 NP LORDOTIC 5-6X15X12
• 00643169362697: TRIAL 66265412 NP LORDOTIC 11-12X15X14
• 00643169362680: TRIAL 66267412 NP LORDOTIC 11-12X17X14
• 00643169362673: TRIAL 66267612 NP LORDOTIC 11-12X17X16
• 00643169362666: TRIAL 66262412 NP LORDOTIC 11-12X20X14
• 00643169362659: TRIAL 66262612 NP LORDOTIC 11-12X20X16
• 00643169362635: TRIAL 66265456 NP LORDOTIC 5-6X15X14
• 00643169362628: TRIAL 66267456 NP LORDOTIC 5-6X17X14
• 00643169362611: TRIAL 66267656 NP LORDOTIC 5-6X17X16
• 00643169362604: TRIAL 66262456 NP LORDOTIC 5-6X20X14
• 00643169362444: TRIAL 66205256 NP PARALLEL 5-6X15X12
• 00643169362437: TRIAL 66205456 NP PARALLEL 5-6X15X14
• 00643169362420: TRIAL 66207456 NP PARALLEL 5-6X17X14
• 00643169362413: TRIAL 66207656 NP PARALLEL 5-6X17X16
• 00643169362406: TRIAL 66202456 NP PARALLEL 5-6X20X14
• 00643169362390: TRIAL 66202656 NP PARALLEL 5-6X20X16
• 00643169362383: TRIAL 66205278 NP PARALLEL 7-8X15X12
• 00643169362376: TRIAL 66205478 NP PARALLEL 7-8X15X14
• 00643169362369: TRIAL 66207478 NP PARALLEL 7-8X17X14