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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, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented
510(K) Number K121665
Device Name BENCOX FORET & BENCOX DELTA
Applicant
CORENTEC CO., LTD
11th chungho tower
748-1 banpo 1 dong
seocho gu, seoul, 
Contact j.s. daniel
Regulation Number888.3353
Classification Product Code
LZO  
Date Received06/06/2012
Decision Date 09/25/2012
Decision substantially equivalent (SE)
Classification Advisory Committee Orthopedic
Review Advisory Committee Orthopedic
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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