E-CLASS® DUAL MOBILITY INSERTS And DYNASTY® DUAL MOBILITY LINERS

Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented

Microport Orthopedics, Inc.

The following data is part of a premarket notification filed by Microport Orthopedics, Inc. with the FDA for E-class® Dual Mobility Inserts And Dynasty® Dual Mobility Liners.

Pre-market Notification Details

Device IDK200011
510k NumberK200011
Device Name:E-CLASS® DUAL MOBILITY INSERTS And DYNASTY® DUAL MOBILITY LINERS
ClassificationProsthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented
Applicant Microport Orthopedics, Inc. 5677 Airline Road Arlington,  TN  38002
ContactKristen Russell
CorrespondentMatthew Paul
Microport Orthopedics, Inc. 5677 Airline Road Arlington,  TN  38002
Product CodeLPH  
Subsequent Product CodeKWY
Subsequent Product CodeLZO
Subsequent Product CodeOQG
CFR Regulation Number888.3358 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-01-02
Decision Date2021-10-01

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
M684DLDMGJ521 K200011 000
M684DMNE28381 K200011 000
M684DLDMGK561 K200011 000
M684DLDMGJ541 K200011 000
M684DLDMGH501 K200011 000
M684DLDMGG461 K200011 000
M684DLDMGF441 K200011 000
M684DLDMGE421 K200011 000
M684DLDMGD401 K200011 000
M684DMNE28401 K200011 000
M684DMNE28421 K200011 000
M684DLDMGH481 K200011 000
M684DMNE28561 K200011 000
M684DMNE28541 K200011 000
M684DMNE28521 K200011 000
M684DMNE28501 K200011 000
M684DMNE28481 K200011 000
M684DMNE28461 K200011 000
M684DMNE28441 K200011 000
M684DLDMGC381 K200011 000

Trademark Results [E-CLASS]

Mark Image

Registration | Serial
Company
Trademark
Application Date
E-CLASS
E-CLASS
87454803 5499215 Live/Registered
MicroPort Orthopedics Holdings Inc.
2017-05-18
E-CLASS
E-CLASS
78095948 not registered Dead/Abandoned
Alcoa Inc.
2001-11-30
E-CLASS
E-CLASS
76126673 2967399 Live/Registered
KARL STORZ SE & CO. KG
2000-09-12
E-CLASS
E-CLASS
76064474 2509266 Dead/Cancelled
Trelleborg Wheel Systems Americas, Inc.
2000-06-07
E-CLASS
E-CLASS
75923691 not registered Dead/Abandoned
Copernicus Interactive, Inc.
2000-02-22
E-CLASS
E-CLASS
74494469 2599862 Live/Registered
DAIMLER AG
1994-02-25
E-CLASS
E-CLASS
74242503 1718166 Dead/Cancelled
Wasco Products, Inc.
1992-02-03
E-CLASS
E-CLASS
74237592 1720033 Dead/Cancelled
KeyTek Instrument Corp.
1992-01-14

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