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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer
510(K) Number K121037
Device Name LOSPA TIBIAL BASE PLATE
Applicant
CORENTEC CO., LTD
11th chungho tower
748-1 banpo 1 dong
seocho gu, seoul, 
Contact j.s. daniel
Regulation Number888.3560
Classification Product Code
JWH  
Date Received04/05/2012
Decision Date 05/03/2012
Decision substantially equivalent (SE)
Classification Advisory Committee Orthopedic
Review Advisory Committee Orthopedic
summary summary
Type Special
Reviewed by Third Party No
Expedited Review No
Combination Product No
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