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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 K231975
Device Name PNK Total Knee System
Applicant
Tjc Life Co., Ltd.
E1812, Dangsan, Skv1 Center, 11
Yeongdengpo-Gu,  KR 07217
Applicant Contact Srinu Krotha
Correspondent
Tjc Life Co., Ltd.
E1812, Dangsan, Skv1 Center, 11
Yeongdengpo-Gu,  KR 07217
Correspondent Contact Srinu Krotha
Regulation Number888.3560
Classification Product Code
JWH  
Date Received07/03/2023
Decision Date 11/21/2023
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
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