VERTEX™ Reconstruction System

Posterior Cervical Screw System

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 Vertex™ Reconstruction System.

Pre-market Notification Details

Device IDK180851
510k NumberK180851
Device Name:VERTEX™ Reconstruction System
ClassificationPosterior Cervical Screw System
Applicant Medtronic Sofamor Danek USA, Inc 1800 Pyramid Place Memphis,  TN  38132
ContactAnkit K Shah
CorrespondentAnkit K Shah
Medtronic Sofamor Danek USA, Inc 1800 Pyramid Place Memphis,  TN  38132
Product CodeNKG  
CFR Regulation Number888.3075 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2018-04-02
Decision Date2018-04-18
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00613994641915 K180851 000
00613994641663 K180851 000
00613994641670 K180851 000
00613994641892 K180851 000
00613994641908 K180851 000
00613994666642 K180851 000
00613994666970 K180851 000
00613994666987 K180851 000
00643169101333 K180851 000
00643169101357 K180851 000
00643169101371 K180851 000
00643169101463 K180851 000
00613994641656 K180851 000

Trademark Results [VERTEX]

Mark Image

Registration | Serial
Company
Trademark
Application Date
VERTEX
VERTEX
98418366 not registered Live/Pending
Albaugh, LLC
2024-02-23
VERTEX
VERTEX
98283922 not registered Live/Pending
SMB DOLLAR INC.
2023-11-24
VERTEX
VERTEX
98003838 not registered Live/Pending
Guangdong Xupai New Energy Co., LTD
2023-05-18
VERTEX
VERTEX
97926020 not registered Live/Pending
BOSU Fitness, LLC
2023-05-08
VERTEX
VERTEX
97842957 not registered Live/Pending
Tony Wang
2023-03-16
VERTEX
VERTEX
97810328 not registered Live/Pending
Neptune Medical Inc.
2023-02-24
VERTEX
VERTEX
97717621 not registered Live/Pending
Alliance Sports Group, L.P.
2022-12-14
VERTEX
VERTEX
97649858 not registered Live/Pending
Alliance Sports Group, L.P.
2022-10-26
VERTEX
VERTEX
97641291 not registered Live/Pending
SeeScan, Inc.
2022-10-20
VERTEX
VERTEX
97563091 not registered Live/Pending
Boxcar USA LLC
2022-08-24
VERTEX
VERTEX
97561847 not registered Live/Pending
East West Manufacturing, LLC
2022-08-24
VERTEX
VERTEX
97521927 not registered Live/Pending
Travis Body and Trailer, Inc.
2022-07-27

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