DIVERGENCE-L™ Anterior/Oblique Lumbar Fusion System

GUDID 00643169523906

TRIAL 2156514 MEDIUM 6 DEGREES 14MM

MEDTRONIC SOFAMOR DANEK, INC.

Bone-screw internal spinal fixation system, non-sterile

• Primary Device ID: 00643169523906
• NIH Device Record Key: 9955eb62-c89b-4429-a044-75216f5ee557
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DIVERGENCE-L™ Anterior/Oblique Lumbar Fusion System
• Version Model Number: 2156514
• 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

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 Identifiers

Device Issuing Agency	Device ID
GS1	00643169523906 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K150135

FDA Product Code

• MAX: Intervertebral fusion device with bone graft, lumbar

Sterilization

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

[00643169523906]

Moist Heat or Steam Sterilization

[00643169523906]

Moist Heat or Steam Sterilization

[00643169523906]

Moist Heat or Steam Sterilization

[00643169523906]

Moist Heat or Steam Sterilization

[00643169523906]

Moist Heat or Steam Sterilization

[00643169523906]

Moist Heat or Steam Sterilization

[00643169523906]

Moist Heat or Steam Sterilization

[00643169523906]

Moist Heat or Steam Sterilization

[00643169523906]

Moist Heat or Steam Sterilization

[00643169523906]

Moist Heat or Steam Sterilization

[00643169523906]

Moist Heat or Steam Sterilization

[00643169523906]

Moist Heat or Steam Sterilization

[00643169523906]

Moist Heat or Steam Sterilization

[00643169523906]

Moist Heat or Steam Sterilization

[00643169523906]

Moist Heat or Steam Sterilization

[00643169523906]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-04-09

On-Brand Devices [DIVERGENCE-L™ Anterior/Oblique Lumbar Fusion System]

• 00643169524880: GUIDE 2160220 ALIF SCREW GUIDE 20MM
• 00643169524873: GUIDE 2160218 ALIF SCREW GUIDE 18MM
• 00643169524866: GUIDE 2160216 ALIF SCREW GUIDE 16MM
• 00643169524859: GUIDE 2160214 ALIF SCREW GUIDE 14MM
• 00643169524842: GUIDE 2160212 ALIF SCREW GUIDE 12MM
• 00643169524835: GUIDE 2160210 ALIF SCREW GUIDE 10MM
• 00643169524828: GUIDE 2150220 O51 SCREW GUIDE 20MM
• 00643169524811: GUIDE 2150218 O51 SCREW GUIDE 18MM
• 00643169524804: GUIDE 2150216 O51 SCREW GUIDE 16MM
• 00643169524798: GUIDE 2150214 O51 SCREW GUIDE 14MM
• 00643169524781: GUIDE 2150212 O51 SCREW GUIDE 12MM
• 00643169524774: GUIDE 2150210 O51 SCREW GUIDE 10MM
• 00643169524767: INSERTER 2160400 ALIF FREEHAND
• 00643169524750: INSERTER 2160300 ALIF SIMPLE PLATE
• 00643169524743: INSERTER 2160200 ALIF SIMPLE INTERBODY
• 00643169524712: REMOVER 2151150 INTERBODY REMOVER
• 00643169524682: INSERTER 2151100 HANDLE INSERTER
• 00643169524644: INSERTER 2150200 O51 SIMPLE INTERBODY
• 00643169524637: INSERTER 2150300 O51 SIMPLE PLATE
• 00643169524620: HANDLE 2150330 TRIAL HANDLE
• 00643169524613: HANDLE 2150340 PLATE TRIAL HANDLE
• 00643169524606: INSERTER 2150400 O51 FREEHAND
• 00643169524545: TRAY 2159004 DIVERGENCE-L TRIALS
• 00643169524491: TRIAL 2156420 SMALL 6 DEGREES 20MM
• 00643169524484: TRIAL 2156418 SMALL 6 DEGREES 18MM
• 00643169524477: TRIAL 2156416 SMALL 6 DEGREES 16MM
• 00643169524460: TRIAL 2156414 SMALL 6 DEGREES 14MM
• 00643169524453: TRIAL 2156412 SMALL 6 DEGREES 12MM
• 00643169524446: TRIAL 2156410 SMALL 6 DEGREES 10MM
• 00643169524439: TRIAL 2154620 LARGE 24 DEGREES 20MM
• 00643169524422: TRIAL 2154618 LARGE 24 DEGREES 18MM
• 00643169524415: TRIAL 2154520 MEDIUM 24 DEGREES 20MM
• 00643169524408: TRIAL 2154518 MEDIUM 24 DEGREES 18MM
• 00643169524392: TRIAL 2154516 MEDIUM 24 DEGREES 16MM
• 00643169524385: TRIAL 2154420 SMALL 24 DEGREES 20MM
• 00643169524378: TRIAL 2154418 SMALL 24 DEGREES 18MM
• 00643169524361: TRIAL 2154416 SMALL 24 DEGREES 16MM
• 00643169524354: TRIAL 2152620 LARGE 12 DEGREES 20MM
• 00643169524347: TRIAL 2152618 LARGE 12 DEGREES 18MM
• 00643169524330: TRIAL 2152616 LARGE 12 DEGREES 16MM
• 00643169524323: TRIAL 2152614 LARGE 12 DEGREES 14MM
• 00643169524316: TRIAL 2152612 LARGE 12 DEGREES 12MM
• 00643169524309: TRIAL 2152520 MEDIUM 12 DEGREES 20MM
• 00643169524293: TRIAL 2152518 MEDIUM 12 DEGREES 18MM
• 00643169524286: TRIAL 2152516 MEDIUM 12 DEGREES 16MM
• 00643169524279: TRIAL 2152514 MEDIUM 12 DEGREES 14MM
• 00643169524262: TRIAL 2152512 MEDIUM 12 DEGREES 12MM
• 00643169524255: TRIAL 2152510 MEDIUM 12 DEGREES 10MM
• 00643169524248: TRIAL 2152420 SMALL 12 DEGREES 20MM
• 00643169524231: TRIAL 2150316 PLATE TRIAL 16MM