PROFEMUR GLADIATOR Thin HA Classic Hip Stem With Collar

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

MicroPort Orthopedics Inc.

The following data is part of a premarket notification filed by Microport Orthopedics Inc. with the FDA for Profemur Gladiator Thin Ha Classic Hip Stem With Collar.

Pre-market Notification Details

Device IDK200007
510k NumberK200007
Device Name:PROFEMUR GLADIATOR Thin HA Classic Hip Stem With Collar
ClassificationProsthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented
Applicant MicroPort Orthopedics Inc. 5677 Airline Road Arlington,  TN  38002
ContactAllen Mamaril
CorrespondentAllen Mamaril
MicroPort Orthopedics Inc. 5677 Airline Road Arlington,  TN  38002
Product CodeLZO  
CFR Regulation Number888.3353 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-01-02
Decision Date2020-04-25

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