Divergence® Anterior Cervical Fusion System

GUDID 00643169363083

GUIDE 6628157 NO-P 7MM X 15MM GUIDE

MEDTRONIC SOFAMOR DANEK, INC.

Orthopaedic implant inserter/extractor, reusable Orthopaedic implant inserter/extractor, reusable
Primary Device ID00643169363083
NIH Device Record Keyd1a5965e-4761-4e5d-862c-0192f844fd41
Commercial Distribution StatusIn Commercial Distribution
Brand NameDivergence® Anterior Cervical Fusion System
Version Model Number6628157
Company DUNS830350380
Company NameMEDTRONIC SOFAMOR DANEK, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com

Device Dimensions

Width15 Millimeter
Width15 Millimeter
Width15 Millimeter
Width15 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS100643169363083 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

OVEIntervertebral fusion device with integrated fixation, cervical

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00643169363083]

Moist Heat or Steam Sterilization


[00643169363083]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number6
Public Version Date2019-04-23
Device Publish Date2015-10-16

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

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

Trademark Results [Divergence]

Mark Image

Registration | Serial
Company
Trademark
Application Date
DIVERGENCE
DIVERGENCE
98062878 not registered Live/Pending
Mid America Pet Food, LLC
2023-06-28
DIVERGENCE
DIVERGENCE
88866198 not registered Live/Pending
Loveland Products, Inc.
2020-04-09
DIVERGENCE
DIVERGENCE
88751831 not registered Live/Pending
NL Enterprises, LLC
2020-01-08
DIVERGENCE
DIVERGENCE
88024730 not registered Dead/Abandoned
Marlabs.inc
2018-07-03
DIVERGENCE
DIVERGENCE
87954231 5904263 Live/Registered
Alexander Marine USA Inc.
2018-06-08
DIVERGENCE
DIVERGENCE
85369051 4679213 Live/Registered
Warsaw Orthopedic, Inc.
2011-07-12
DIVERGENCE
DIVERGENCE
79285718 not registered Live/Pending
THE SPIRITS WORKSHOP LIMITED
2020-04-14
DIVERGENCE
DIVERGENCE
78976617 3059656 Dead/Cancelled
DIVERGENCE, INC.
2001-06-21
DIVERGENCE
DIVERGENCE
78873601 3826516 Dead/Cancelled
Divergence, Inc.
2006-05-01
DIVERGENCE
DIVERGENCE
78112801 not registered Dead/Abandoned
DIVERGENCE, INC.
2002-03-05
DIVERGENCE
DIVERGENCE
78070259 3308002 Dead/Cancelled
DIVERGENCE, INC.
2001-06-21

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