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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 K222278
Device Name LOSPA TKR System Instrumentation, EXULT TKR System Instrumentation
Applicant
Corentec Co., Ltd.
12, Yeongsanhong 1-gil, Ipjang-myeon, Seobuk-gu,
Cheonan-si, Chungchongnam-do
Cheonan-si,  KR 31056
Applicant Contact Yoorim Bae
Correspondent
Corentec Co., Ltd.
12, Yeongsanhong 1-gil, Ipjang-Myeon, Seobuk-Gu,
Cheonan-si, Chungchongnam-do
Cheonan-si,  KR 31056
Correspondent Contact Yoorim Bae
Regulation Number888.3560
Classification Product Code
JWH  
Subsequent Product Codes
MBH   OQG  
Date Received07/29/2022
Decision Date 08/26/2022
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
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