Divergence® Anterior Cervical Fusion System
GUDID 00643169338616
SCREW G6634016 NoP S-T 4.0mm x 16mm
MEDTRONIC SOFAMOR DANEK, INC.
Spinal bone screw, non-bioabsorbable| Primary Device ID | 00643169338616 |
| NIH Device Record Key | 746db76b-a7e8-4b99-b7d2-160ea4abbc9d |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Divergence® Anterior Cervical Fusion System |
| Version Model Number | G6634016 |
| 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
Device Dimensions
| Outer Diameter | 4 Millimeter |
| Outer Diameter | 4 Millimeter |
| Outer Diameter | 4 Millimeter |
| Outer Diameter | 4 Millimeter |
| Length | 16 Millimeter |
| Outer Diameter | 4 Millimeter |
| Length | 16 Millimeter |
| Outer Diameter | 4 Millimeter |
| Length | 16 Millimeter |
| Outer Diameter | 4 Millimeter |
| Length | 16 Millimeter |
| Outer Diameter | 4 Millimeter |
| Length | 16 Millimeter |
| Outer Diameter | 4 Millimeter |
| Length | 16 Millimeter |
| Outer Diameter | 4 Millimeter |
| Length | 16 Millimeter |
| Outer Diameter | 4 Millimeter |
| Length | 16 Millimeter |
| Outer Diameter | 4 Millimeter |
| Length | 16 Millimeter |
| Outer Diameter | 4 Millimeter |
| Length | 16 Millimeter |
| Outer Diameter | 4 Millimeter |
| Length | 16 Millimeter |
| Outer Diameter | 4 Millimeter |
| Length | 16 Millimeter |
| Outer Diameter | 4 Millimeter |
| Length | 16 Millimeter |
| Outer Diameter | 4 Millimeter |
| Length | 16 Millimeter |
| Outer Diameter | 4 Millimeter |
| Length | 16 Millimeter |
| Outer Diameter | 4 Millimeter |
| Length | 16 Millimeter |
| Outer Diameter | 4 Millimeter |
| Length | 16 Millimeter |
| Outer Diameter | 4 Millimeter |
| Length | 16 Millimeter |
| Outer Diameter | 4 Millimeter |
| Length | 16 Millimeter |
| Outer Diameter | 4 Millimeter |
| Length | 16 Millimeter |
| Outer Diameter | 4 Millimeter |
| Length | 16 Millimeter |
| Outer Diameter | 4 Millimeter |
| Length | 16 Millimeter |
| Outer Diameter | 4 Millimeter |
| Length | 16 Millimeter |
| Outer Diameter | 4 Millimeter |
| Length | 16 Millimeter |
| Outer Diameter | 4 Millimeter |
| Length | 16 Millimeter |
| Outer Diameter | 4 Millimeter |
| Length | 16 Millimeter |
| Outer Diameter | 4 Millimeter |
| Length | 16 Millimeter |
| Outer Diameter | 4 Millimeter |
| Length | 16 Millimeter |
| Outer Diameter | 4 Millimeter |
| Length | 16 Millimeter |
| Outer Diameter | 4 Millimeter |
| Length | 16 Millimeter |
| Outer Diameter | 4 Millimeter |
| Length | 16 Millimeter |
| Outer Diameter | 4 Millimeter |
| Length | 16 Millimeter |
| Outer Diameter | 4 Millimeter |
| Length | 16 Millimeter |
| Outer Diameter | 4 Millimeter |
| Length | 16 Millimeter |
| Outer Diameter | 4 Millimeter |
| Length | 16 Millimeter |
| Outer Diameter | 4 Millimeter |
| Length | 16 Millimeter |
| Outer Diameter | 4 Millimeter |
| Length | 16 Millimeter |
| Outer Diameter | 4 Millimeter |
| Length | 16 Millimeter |
| Outer Diameter | 4 Millimeter |
| Length | 16 Millimeter |
| Outer Diameter | 4 Millimeter |
| Length | 16 Millimeter |
| Outer Diameter | 4 Millimeter |
| Length | 16 Millimeter |
| Outer Diameter | 4 Millimeter |
| Length | 16 Millimeter |
| Outer Diameter | 4 Millimeter |
| Length | 16 Millimeter |
| Outer Diameter | 4 Millimeter |
| Length | 16 Millimeter |
| Outer Diameter | 4 Millimeter |
| Length | 16 Millimeter |
| Outer Diameter | 4 Millimeter |
| Length | 16 Millimeter |
| Outer Diameter | 4 Millimeter |
| Length | 16 Millimeter |
| Outer Diameter | 4 Millimeter |
| Length | 16 Millimeter |
| Outer Diameter | 4 Millimeter |
| Length | 16 Millimeter |
| Outer Diameter | 4 Millimeter |
| Length | 16 Millimeter |
| Outer Diameter | 4 Millimeter |
| Length | 16 Millimeter |
| Outer Diameter | 4 Millimeter |
| Length | 16 Millimeter |
| Outer Diameter | 4 Millimeter |
| Length | 16 Millimeter |
| Outer Diameter | 4 Millimeter |
| Length | 16 Millimeter |
| Outer Diameter | 4 Millimeter |
| Length | 16 Millimeter |
| Outer Diameter | 4 Millimeter |
| Length | 16 Millimeter |
| Outer Diameter | 4 Millimeter |
| Length | 16 Millimeter |
| Outer Diameter | 4 Millimeter |
| Length | 16 Millimeter |
| Outer Diameter | 4 Millimeter |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00643169338616 [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 | 4 |
| Public Version Date | 2019-04-09 |
| 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 |
Trademark Results [Divergence]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 DIVERGENCE 98062878 not registered Live/Pending |
Mid America Pet Food, LLC 2023-06-28 |
 DIVERGENCE 88866198 not registered Live/Pending |
Loveland Products, Inc. 2020-04-09 |
 DIVERGENCE 88751831 not registered Live/Pending |
NL Enterprises, LLC 2020-01-08 |
 DIVERGENCE 88024730 not registered Dead/Abandoned |
Marlabs.inc 2018-07-03 |
 DIVERGENCE 87954231 5904263 Live/Registered |
Alexander Marine USA Inc. 2018-06-08 |
 DIVERGENCE 85369051 4679213 Live/Registered |
Warsaw Orthopedic, Inc. 2011-07-12 |
 DIVERGENCE 79285718 not registered Live/Pending |
THE SPIRITS WORKSHOP LIMITED 2020-04-14 |
 DIVERGENCE 78976617 3059656 Dead/Cancelled |
DIVERGENCE, INC. 2001-06-21 |
 DIVERGENCE 78873601 3826516 Dead/Cancelled |
Divergence, Inc. 2006-05-01 |
 DIVERGENCE 78112801 not registered Dead/Abandoned |
DIVERGENCE, INC. 2002-03-05 |
 DIVERGENCE 78070259 3308002 Dead/Cancelled |
DIVERGENCE, INC. 2001-06-21 |
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.