Bencox M Stem (Bencox Hip System) And Bencox ID Cemented Stem (with Centralizer) & Bencox Bone Plug

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

CORENTEC CO., LTD

The following data is part of a premarket notification filed by Corentec Co., Ltd with the FDA for Bencox M Stem (bencox Hip System) And Bencox Id Cemented Stem (with Centralizer) & Bencox Bone Plug.

Pre-market Notification Details

Device IDK152084
510k NumberK152084
Device Name:Bencox M Stem (Bencox Hip System) And Bencox ID Cemented Stem (with Centralizer) & Bencox Bone Plug
ClassificationProsthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented
Applicant CORENTEC CO., LTD 12, YEONGSANHONG 1-GIL, IPJANG-MYEON Cheonan-si,  KR 331-822
ContactJ S Daniel
CorrespondentJ S Daniel
CORENTEC CO., LTD 8F CHUNGHO TOWER, 483, GANGNAM-DAERO Seocho Gu, Seoul,  KR 137-040
Product CodeLPH  
Subsequent Product CodeJDI
Subsequent Product CodeKWY
Subsequent Product CodeLZO
CFR Regulation Number888.3358 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2015-07-27
Decision Date2016-04-29
Summary:summary

NIH GUDID Devices

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