PROFEMUR® GLADIATOR® Cemented Classic Stem

Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented

MicroPort Orthopedics Inc.

The following data is part of a premarket notification filed by Microport Orthopedics Inc. with the FDA for Profemur® Gladiator® Cemented Classic Stem.

Pre-market Notification Details

Device IDK201519
510k NumberK201519
Device Name:PROFEMUR® GLADIATOR® Cemented Classic Stem
ClassificationProsthesis, Hip, Semi-constrained, Metal/polymer, Cemented
Applicant MicroPort Orthopedics Inc. 5677 Airline Road Arlington,  TN  38002
ContactKristen Russell
CorrespondentAllen Mamaril
MicroPort Orthopedics Inc. 5677 Airline Road Arlington,  TN  38002
Product CodeJDI  
Subsequent Product CodeKWL
Subsequent Product CodeKWY
Subsequent Product CodeLZO
CFR Regulation Number888.3350 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-06-08
Decision Date2020-12-10

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
M684PRGCME121 K201519 000
M684PRGCCMS61 K201519 000
M684PRGCCMS81 K201519 000
M684PRGCCME41 K201519 000
M684PRGCCME61 K201519 000
M684PRGCCME81 K201519 000
M684PRGCMS101 K201519 000
M684PRGCMS121 K201519 000
M684PRGCME101 K201519 000
M684PRGCCMS41 K201519 000

Trademark Results [PROFEMUR]

Mark Image

Registration | Serial
Company
Trademark
Application Date
PROFEMUR
PROFEMUR
76380670 2692765 Live/Registered
Wright Medical Technology, Inc.
2002-03-11

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