SOVEREIGN™ Spinal System

GUDID 00643169659032

SPACER 78680812 SV PTC M 37X27X12 8D CP

MEDTRONIC SOFAMOR DANEK, INC.

Bone-screw internal spinal fixation system, sterile
Primary Device ID00643169659032
NIH Device Record Keybf07d921-3804-4123-abf5-8b02834c3261
Commercial Distribution StatusIn Commercial Distribution
Brand NameSOVEREIGN™ Spinal System
Version Model Number78680812
Company DUNS830350380
Company NameMEDTRONIC SOFAMOR DANEK, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Conditional
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
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
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com

Device Dimensions

Height12 Millimeter
Height12 Millimeter
Height12 Millimeter
Height12 Millimeter
Height12 Millimeter
Height12 Millimeter
Width27 Millimeter
Length37 Millimeter
Height12 Millimeter
Width27 Millimeter
Length37 Millimeter
Height12 Millimeter
Width27 Millimeter
Length37 Millimeter
Height12 Millimeter
Width27 Millimeter
Length37 Millimeter
Height12 Millimeter
Width27 Millimeter
Length37 Millimeter
Height12 Millimeter
Width27 Millimeter
Length37 Millimeter
Height12 Millimeter
Width27 Millimeter
Length37 Millimeter
Height12 Millimeter
Width27 Millimeter
Length37 Millimeter
Height12 Millimeter
Width27 Millimeter
Length37 Millimeter
Height12 Millimeter
Width27 Millimeter
Length37 Millimeter
Height12 Millimeter
Width27 Millimeter
Length37 Millimeter
Height12 Millimeter
Width27 Millimeter
Length37 Millimeter
Height12 Millimeter
Width27 Millimeter
Length37 Millimeter
Height12 Millimeter
Width27 Millimeter
Length37 Millimeter
Height12 Millimeter
Width27 Millimeter
Length37 Millimeter
Height12 Millimeter
Width27 Millimeter
Length37 Millimeter
Height12 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS100643169659032 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

OVDIntervertebral fusion device with integrated fixation, lumbar

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00643169659032]

Moist Heat or Steam Sterilization

[00643169659032]

Moist Heat or Steam Sterilization

[00643169659032]

Moist Heat or Steam Sterilization

[00643169659032]

Moist Heat or Steam Sterilization

[00643169659032]

Moist Heat or Steam Sterilization

[00643169659032]

Moist Heat or Steam Sterilization

[00643169659032]

Moist Heat or Steam Sterilization

[00643169659032]

Moist Heat or Steam Sterilization

[00643169659032]

Moist Heat or Steam Sterilization

[00643169659032]

Moist Heat or Steam Sterilization

[00643169659032]

Moist Heat or Steam Sterilization

[00643169659032]

Moist Heat or Steam Sterilization

[00643169659032]

Moist Heat or Steam Sterilization

[00643169659032]

Moist Heat or Steam Sterilization

[00643169659032]

Moist Heat or Steam Sterilization

[00643169659032]

Moist Heat or Steam Sterilization

[00643169659032]

Moist Heat or Steam Sterilization

[00643169659032]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number2
Public Version Date2018-07-06
Device Publish Date2018-03-02

On-Brand Devices [SOVEREIGN™ Spinal System]

00613994736611SCREW 7975520 SOVEREIGN FA 5.5 X 20MM
00613994736598SCREW 7975525 SOVEREIGN FA 5.5 X 25MM
00613994736574SCREW 7975530 SOVEREIGN FA 5.5 X 30MM
00613994736550SCREW 7975535 SOVEREIGN FA 5.5 X 35MM
00613994736536SCREW 7976020 SOVEREIGN FA 6.0 X 20MM
00613994736512SCREW 7976025 SOVEREIGN FA 6.0 X 25MM
00613994736499SCREW 7976030 SOVEREIGN FA 6.0 X 30MM
00613994736475SCREW 7976035 SOVEREIGN FA 6.0 X 35MM
00613994545329SHAFT 7967081 L INSERTER
00613994545312SHAFT 7967080 M INSERTER
00613994545305SHAFT 7967079 S INSERTER
00613994513489SCREW Y7966030 6.0 X 30MM SELF-TAP
00613994513472SCREW Y7966025 6.0 X 25MM SELF-TAP
00613994513458SCREW Y7965525 5.5 X 25MM SELF-TAP
00613994504234SPACER Y7968816 M 37X27X 16MM, 8 DEG
00613994504227SPACER Y7968814 M 37X27X 14MM, 8 DEG
00613994504210SPACER Y7968812 M 37X27X 12MM, 8 DEG
00613994504203COVERPLATE Y7968330 MEDIUM
00613994504197SPACER Y7967816 S 32X23X 16MM, 8 DEG
00613994504180SPACER Y7967814 S 32X23X 14MM, 8 DEG
00613994504173SPACER Y7967812 S 32X23X 12MM, 8 DEG
00613994504166COVERPLATE Y7967330 SMALL
00613994501929SCREW 7966035 6.0MM X 35MM SELF TAP
00613994501912SCREW 7966030 6.0MM X 30MM SELF TAP
00613994501905SCREW 7966025 6.0MM X 25MM SELF TAP
00613994501899SCREW 7966020 6.0MM X 20MM SELF TAP
00613994501875SCREW 7965535 5.5MM X 35MM SELF TAP
00613994501868SCREW 7965530 5.5MM X 30MM SELF TAP
00613994501851SCREW 7965525 5.5MM X 25MM SELF TAP
00613994501844SCREW 7965520 5.5MM X 20MM SELF TAP
00613994501004ASSEMBLY 7967210 S 32X23 10MM 12DEG CP
00613994500991ASSEMBLY 7967212 S 32X23 12MM 12DEG CP
00613994500984ASSEMBLY 7967214 S 32X23 14MM 12DEG CP
00613994500977SPACER 7967216 S 32 X 23 X16MM 12 DEG
00613994500960ASSEMBLY 7967218 S 32X23 18MM 12DEG CP
00613994500953SPACER 7967220 S 32 X 23 X20MM 12 DEG
00613994500946ASSEMBLY 7967222 S 32X23 22MM 12DEG CP
00613994500939SPACER 7967224 S 32 X 23 X24MM 12 DEG
00613994500922SPACER 7967810 S 32 X 23 X10MM 8 DEG
00613994500915ASSEMBLY 7967812 S 32X23 12MM 8DEG CP
00613994500908SPACER 7967814 S 32 X 23 X14MM 8 DEG
00613994500892ASSEMBLY 7967816 S 32X23 16MM 8DEG CP
00613994500885ASSEMBLY 7967818 S 32X23 18MM 8DEG CP
00613994500878ASSEMBLY 7967820 S 32X23 20MM 8DEG CP
00613994500861ASSEMBLY 7967822 S 32X23 22MM 8DEG CP
00613994500854SPACER 7967824 S 32 X 23 X24MM 8 DEG
00613994321176SHAFT 7967007 S INSERTER
00613994321169SHAFT 7967008 M INSERTER
00613994321152SHAFT 7967009 L INSERTER
00613994321121INSERTER 7967012 CP

Trademark Results [SOVEREIGN]

Mark Image

Registration | Serial
Company
Trademark
Application Date
SOVEREIGN
SOVEREIGN
98193602 not registered Live/Pending
Shenzhen Hongyihuiteng Network Technology Co., Ltd.
2023-09-22
SOVEREIGN
SOVEREIGN
98188246 not registered Live/Pending
Natural Immunogenics Corp.
2023-09-20
SOVEREIGN
SOVEREIGN
97671859 not registered Live/Pending
Sovereign Labs Inc.
2022-11-10
SOVEREIGN
SOVEREIGN
97395805 not registered Live/Pending
AxesNetwork Solutions, Inc.
2022-05-05
SOVEREIGN
SOVEREIGN
97062010 not registered Live/Pending
DTS Chicago, Inc.
2021-10-06
SOVEREIGN
SOVEREIGN
97060323 not registered Live/Pending
DTS Chicago, Inc.
2021-10-05
SOVEREIGN
SOVEREIGN
97060232 not registered Live/Pending
DTS Chicago, Inc.
2021-10-05
SOVEREIGN
SOVEREIGN
90862433 not registered Live/Pending
Drew Layne, LLC
2021-08-03
SOVEREIGN
SOVEREIGN
90386918 not registered Live/Pending
Sovereign Kingdom
2020-12-16
SOVEREIGN
SOVEREIGN
88794699 not registered Live/Pending
Aesculap, Inc.
2020-02-12
SOVEREIGN
SOVEREIGN
88500152 not registered Live/Pending
Sovereign Chemical Company
2019-07-03
SOVEREIGN
SOVEREIGN
87590154 not registered Dead/Abandoned
Northern Brewer LLC
2017-08-30
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