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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented
510(k) Number K112019
Device Name BENCOX ID STEM, BENCOX METAL HEAD, BENCOX BIPOLAR CUP
Applicant
Corentec Co., Ltd.
11th Chungho Tower, 748-1 Banpo 1 Dong
Seocho Gu, Seoul,  KR 137-040
Applicant Contact J.S. DANIEL
Correspondent
Corentec Co., Ltd.
11th Chungho Tower, 748-1 Banpo 1 Dong
Seocho Gu, Seoul,  KR 137-040
Correspondent Contact J.S. DANIEL
Regulation Number888.3390
Classification Product Code
KWY  
Subsequent Product Code
LPH  
Date Received07/14/2011
Decision Date 10/12/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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