Stratum® Ankle Fusion Plating System

Plate, Fixation, Bone

Nextremity Solutions, Inc.

The following data is part of a premarket notification filed by Nextremity Solutions, Inc. with the FDA for Stratum® Ankle Fusion Plating System.

Pre-market Notification Details

Device IDK212640
510k NumberK212640
Device Name:Stratum® Ankle Fusion Plating System
ClassificationPlate, Fixation, Bone
Applicant Nextremity Solutions, Inc. 1195 Polk Drive Warsaw,  IN  46582
ContactElise Fox
CorrespondentElise Fox
Nextremity Solutions, Inc. 1195 Polk Drive Warsaw,  IN  46582
Product CodeHRS  
Subsequent Product CodeHWC
Subsequent Product CodeKCT
Subsequent Product CodeLXH
CFR Regulation Number888.3030 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-08-20
Decision Date2021-11-18

Trademark Results [Stratum]

Mark Image

Registration | Serial
Company
Trademark
Application Date
STRATUM
STRATUM
90825780 not registered Live/Pending
Spigen Korea Co., Ltd.
2021-07-13
STRATUM
STRATUM
88789373 not registered Live/Pending
Laurentia Wines, LLC
2020-02-07
STRATUM
STRATUM
88445824 not registered Live/Pending
Whitson Technologies
2019-05-24
STRATUM
STRATUM
88252355 5812759 Live/Registered
IKO Imports LLC
2019-01-07
STRATUM
STRATUM
87891005 not registered Live/Pending
Kenneth K. Huber
2018-04-24
STRATUM
STRATUM
87680007 not registered Dead/Abandoned
Modne, Inc.
2017-11-10
STRATUM
STRATUM
87677802 not registered Live/Pending
NEXTREMITY SOLUTIONS, INC.
2017-11-09
STRATUM
STRATUM
87501397 not registered Live/Pending
Loveland Products, Inc.
2017-06-22
STRATUM
STRATUM
86881136 5115902 Live/Registered
DATICA HEALTH, INC.
2016-01-20
STRATUM
STRATUM
86817846 5120846 Live/Registered
Douglas Machine Inc.
2015-11-12
STRATUM
STRATUM
86535783 5314510 Live/Registered
Tensar Technologies Limited
2015-02-16
STRATUM
STRATUM
86529665 5519868 Live/Registered
SHAW INDUSTRIES GROUP, INC.
2015-02-10

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