SOVEREIGN® Spinal System

Intervertebral Fusion Device With Integrated Fixation, Lumbar

MEDTRONIC SOFAMOR DANEK USA, INC.

The following data is part of a premarket notification filed by Medtronic Sofamor Danek Usa, Inc. with the FDA for Sovereign® Spinal System.

Pre-market Notification Details

Device IDK162680
510k NumberK162680
Device Name:SOVEREIGN® Spinal System
ClassificationIntervertebral Fusion Device With Integrated Fixation, Lumbar
Applicant MEDTRONIC SOFAMOR DANEK USA, INC. 1800 PYRAMID PLACE Memphis,  TN  38132
ContactKanesha Hines
CorrespondentKanesha Hines
MEDTRONIC SOFAMOR DANEK USA, INC. 1800 PYRAMID PLACE Memphis,  TN  38132
Product CodeOVD  
CFR Regulation Number888.3080 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2016-09-26
Decision Date2016-12-14

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00613994565983 K162680 000
00643169636804 K162680 000
00643169636811 K162680 000
00643169636828 K162680 000
00643169636835 K162680 000
00643169636842 K162680 000
00643169636859 K162680 000
00643169636866 K162680 000
00643169636873 K162680 000
00643169636880 K162680 000
00643169636897 K162680 000
00643169636798 K162680 000
00643169636781 K162680 000
00643169636774 K162680 000
00613994565976 K162680 000
00643169415973 K162680 000
00643169415980 K162680 000
00643169561540 K162680 000
00643169561557 K162680 000
00643169561564 K162680 000
00643169561571 K162680 000
00643169636743 K162680 000
00643169636750 K162680 000
00643169636767 K162680 000
00643169636903 K162680 000
00643169636910 K162680 000
00643169637054 K162680 000
00643169637061 K162680 000
00643169637078 K162680 000
00643169637085 K162680 000
00643169637092 K162680 000
00643169646001 K162680 000
00643169646018 K162680 000
00643169702950 K162680 000
00643169721517 K162680 000
00643169794658 K162680 000
00643169637047 K162680 000
00643169637030 K162680 000
00643169637023 K162680 000
00643169636927 K162680 000
00643169636934 K162680 000
00643169636941 K162680 000
00643169636958 K162680 000
00643169636965 K162680 000
00643169636972 K162680 000
00643169636989 K162680 000
00643169636996 K162680 000
00643169637009 K162680 000
00643169637016 K162680 000
00643169794665 K162680 000

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

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.