Platform® Acetabular System

Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented

Total Joint Orthopedics, Inc.

The following data is part of a premarket notification filed by Total Joint Orthopedics, Inc. with the FDA for Platform® Acetabular System.

Pre-market Notification Details

Device IDK220483
510k NumberK220483
Device Name:Platform® Acetabular System
ClassificationProsthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented
Applicant Total Joint Orthopedics, Inc. 1567 E. Stratford Avenue Salt Lake City,  UT  84106
ContactChris Weaber
CorrespondentHolly Rhodes
Mcra LLC. 803 7th Street NW Washington,  DC  20001
Product CodeLZO  
Subsequent Product CodeLPH
Subsequent Product CodeMBL
Subsequent Product CodeOQG
CFR Regulation Number888.3353 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2022-02-18
Decision Date2022-09-23

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
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00814703017117 K220483 000

Trademark Results [Platform]

Mark Image

Registration | Serial
Company
Trademark
Application Date
PLATFORM
PLATFORM
98570995 not registered Live/Pending
Platform USA LLC
2024-05-28
PLATFORM
PLATFORM
97531122 not registered Live/Pending
Joint Development, LLC
2022-08-02
PLATFORM
PLATFORM
97372609 not registered Live/Pending
Marc D'Amelio
2022-04-20
PLATFORM
PLATFORM
90978542 not registered Live/Pending
Runyon Group, LLC
2021-06-24
PLATFORM
PLATFORM
90793875 not registered Live/Pending
Runyon Group, LLC
2021-06-24
PLATFORM
PLATFORM
90678754 not registered Live/Pending
Feiner Investments LLC
2021-04-28
PLATFORM
PLATFORM
90521574 not registered Live/Pending
Kadey Holdings, LLC
2021-02-09
PLATFORM
PLATFORM
90408361 not registered Live/Pending
David Zwirner Digigal, LLC
2020-12-23
PLATFORM
PLATFORM
90239968 not registered Live/Pending
Nufarm Americas Inc.
2020-10-07
PLATFORM
PLATFORM
90040068 not registered Live/Pending
Spark Boulder Owner LLC
2020-07-07
PLATFORM
PLATFORM
88940266 not registered Live/Pending
Kai U.S.A., Ltd.
2020-05-29
PLATFORM
PLATFORM
88667763 not registered Live/Pending
SPORT AND WELLNESS LIVING LTD
2019-10-24

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