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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 K130673
Device Name LOSPA TOTAL KNEE REPLACEMENT SYSTEM
Applicant
CORENTEC CO., LTD
8TH CHUNGHO TOWER, 748-1 BANPO 1 DONG
SEOCHO GU, SEOUL,  KR 137-040
Applicant Contact J.S. DANIEL
Correspondent
CORENTEC CO., LTD
8TH CHUNGHO TOWER, 748-1 BANPO 1 DONG
SEOCHO GU, SEOUL,  KR 137-040
Correspondent Contact J.S. DANIEL
Regulation Number888.3560
Classification Product Code
JWH  
Date Received03/12/2013
Decision Date 04/15/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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