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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 K160157
Device Name LOSPA Modular Knee System
Applicant
CORENTEC CO., LTD
12, Yeongsanhong 1-gil, Ipjang-Myeon,
CHEONAN-SI,  KR 331-822
Applicant Contact Goon Hee Lee
Correspondent
CORENTEC CO., LTD
8F CHUNGHO TOWER, 483, GANGNAM-DAERO
SEOCHO GU, SEOUL,  KR 137-040
Correspondent Contact J. S. DANIEL
Regulation Number888.3560
Classification Product Code
JWH  
Date Received01/22/2016
Decision Date 12/01/2016
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
Recalls CDRH Recalls
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