SOVEREIGN™ Spinal System

GUDID 00643169658981

SPACER 78673020 SV PTC S 32X23X20 30D CP

MEDTRONIC SOFAMOR DANEK, INC.

Bone-screw internal spinal fixation system, sterile

Primary Device ID	00643169658981
NIH Device Record Key	fab7079a-b391-4979-8d0a-9349580d0806
Commercial Distribution Status	In Commercial Distribution
Brand Name	SOVEREIGN™ Spinal System
Version Model Number	78673020
Company DUNS	830350380
Company Name	MEDTRONIC SOFAMOR DANEK, INC.
Device Count	1
DM Exempt	false
Pre-market Exempt	false
MRI Safety Status	MR Conditional
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

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

Device Dimensions

Width	23 Millimeter
Width	23 Millimeter
Width	23 Millimeter
Width	23 Millimeter
Width	23 Millimeter
Width	23 Millimeter
Length	32 Millimeter
Height	20 Millimeter
Width	23 Millimeter
Length	32 Millimeter
Height	20 Millimeter
Width	23 Millimeter
Length	32 Millimeter
Height	20 Millimeter
Width	23 Millimeter
Length	32 Millimeter
Height	20 Millimeter
Width	23 Millimeter
Length	32 Millimeter
Height	20 Millimeter
Width	23 Millimeter
Length	32 Millimeter
Height	20 Millimeter
Width	23 Millimeter
Length	32 Millimeter
Height	20 Millimeter
Width	23 Millimeter
Length	32 Millimeter
Height	20 Millimeter
Width	23 Millimeter
Length	32 Millimeter
Height	20 Millimeter
Width	23 Millimeter
Length	32 Millimeter
Height	20 Millimeter
Width	23 Millimeter
Length	32 Millimeter
Height	20 Millimeter
Width	23 Millimeter
Length	32 Millimeter
Height	20 Millimeter
Width	23 Millimeter
Length	32 Millimeter
Height	20 Millimeter
Width	23 Millimeter
Length	32 Millimeter
Height	20 Millimeter
Width	23 Millimeter
Length	32 Millimeter
Height	20 Millimeter
Width	23 Millimeter
Length	32 Millimeter
Height	20 Millimeter
Width	23 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00643169658981 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K172328

FDA Product Code

OVD	Intervertebral fusion device with integrated fixation, lumbar

Sterilization

Steralize Prior To Use	true
Device Is Sterile	false

[00643169658981]

Moist Heat or Steam Sterilization

[00643169658981]

Moist Heat or Steam Sterilization

[00643169658981]

Moist Heat or Steam Sterilization

[00643169658981]

Moist Heat or Steam Sterilization

[00643169658981]

Moist Heat or Steam Sterilization

[00643169658981]

Moist Heat or Steam Sterilization

[00643169658981]

Moist Heat or Steam Sterilization

[00643169658981]

Moist Heat or Steam Sterilization

[00643169658981]

Moist Heat or Steam Sterilization

[00643169658981]

Moist Heat or Steam Sterilization

[00643169658981]

Moist Heat or Steam Sterilization

[00643169658981]

Moist Heat or Steam Sterilization

[00643169658981]

Moist Heat or Steam Sterilization

[00643169658981]

Moist Heat or Steam Sterilization

[00643169658981]

Moist Heat or Steam Sterilization

[00643169658981]

Moist Heat or Steam Sterilization

[00643169658981]

Moist Heat or Steam Sterilization

[00643169658981]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version Status	New
Device Record Status	Published
Public Version Number	2
Public Version Date	2018-07-06
Device Publish Date	2018-03-02

On-Brand Devices [SOVEREIGN™ Spinal System]

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

Trademark Results [SOVEREIGN]

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

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