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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 K182370
Device Name Acculoc Total Knee System
Applicant
Rootloc Co., Ltd.
#1206, 1210, 68, Digital-Ro 9-Gil, Geumcheon-Gu
Seoul,  KR 08512
Applicant Contact Jungsun Ha
Correspondent
Rootloc Co., Ltd.
#1206, 1210, 68, Digital-Ro 9-Gil, Geumcheon-Gu
Seoul,  KR 08512
Correspondent Contact Jungsun Ha
Regulation Number888.3560
Classification Product Code
JWH  
Date Received08/31/2018
Decision Date 09/27/2018
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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