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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 K242046
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 Seo Sanghee
Correspondent
Corentec Co., Ltd.
33-2, Banpo-Daero 20-Gil, Seocho-Gu
Seoul,  KR 06649
Correspondent Contact Seo Sanghee
Regulation Number888.3560
Classification Product Code
JWH  
Date Received07/12/2024
Decision Date 08/01/2024
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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