KeYi Total Hip System

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

Beijing KeYi Medical Device Technology Co., Ltd.

The following data is part of a premarket notification filed by Beijing Keyi Medical Device Technology Co., Ltd. with the FDA for Keyi Total Hip System.

Pre-market Notification Details

Device IDK191826
510k NumberK191826
Device Name:KeYi Total Hip System
ClassificationProsthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented
Applicant Beijing KeYi Medical Device Technology Co., Ltd. Building 1, 30 Yongchang South Road Beijing,  CN 100176
ContactJenny Jiang
CorrespondentJenny Jiang
Beijing KeYi Medical Device Technology Co., Ltd. Building 1, 30 Yongchang South Road Beijing,  CN 100176
Product CodeLPH  
CFR Regulation Number888.3358 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-07-08
Decision Date2020-05-14

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