DIVERGENCE-L™ Anterior/Oblique Lumbar Fusion System
GUDID 00643169524354
TRIAL 2152620 LARGE 12 DEGREES 20MM
MEDTRONIC SOFAMOR DANEK, INC.
Bone-screw internal spinal fixation system, sterile| Primary Device ID | 00643169524354 |
| NIH Device Record Key | f6c69108-2c4d-456e-b1bf-2143cbfd5578 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | DIVERGENCE-L™ Anterior/Oblique Lumbar Fusion System |
| Version Model Number | 2152620 |
| 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 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| 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 | 00643169524354 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K150135
FDA Product Code
| OVD | Intervertebral fusion device with integrated fixation, lumbar |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00643169524354]
Moist Heat or Steam Sterilization
[00643169524354]
Moist Heat or Steam Sterilization
[00643169524354]
Moist Heat or Steam Sterilization
[00643169524354]
Moist Heat or Steam Sterilization
[00643169524354]
Moist Heat or Steam Sterilization
[00643169524354]
Moist Heat or Steam Sterilization
[00643169524354]
Moist Heat or Steam Sterilization
[00643169524354]
Moist Heat or Steam Sterilization
[00643169524354]
Moist Heat or Steam Sterilization
[00643169524354]
Moist Heat or Steam Sterilization
[00643169524354]
Moist Heat or Steam Sterilization
[00643169524354]
Moist Heat or Steam Sterilization
[00643169524354]
Moist Heat or Steam Sterilization
[00643169524354]
Moist Heat or Steam Sterilization
[00643169524354]
Moist Heat or Steam Sterilization
[00643169524354]
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 |
Trademark Results [DIVERGENCE-L]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 DIVERGENCE-L 86438209 4871814 Live/Registered |
Warsaw Orthopedic, Inc. 2014-10-29 |
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