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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 K250889
Device Name EXULT Knee Replacement System
Applicant
Corentec Co., Ltd.
12, Yeongsanhong 1-Gil, Ipjang-Myeon, Seobuk-Gu, Cheonan-Si
Chungchongnam-Do,  KR 31056
Applicant Contact Sanghee Seo
Correspondent
Corentec Co., Ltd.
12, Yeongsanhong 1-Gil, Ipjang-Myeon, Seobuk-Gu, Cheonan-Si
Chungchongnam-Do,  KR 31056
Correspondent Contact Sanghee Seo
Regulation Number888.3560
Classification Product Code
JWH  
Date Received03/25/2025
Decision Date 04/17/2025
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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