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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Arthroscope
510(k) Number K162070
Device Name JOINIX CANNULAR SYSTEM
Applicant
Aju Pharm Co., Ltd.
A-207, 697, Pangyo-Ro
Seongnam-Si,  KR 13511
Applicant Contact Kim Jung Gil
Correspondent
Plusglobal
300, Atwood St.
Pittsburgh,  PA  15213
Correspondent Contact Peter Chung
Regulation Number888.1100
Classification Product Code
HRX  
Date Received07/27/2016
Decision Date 03/16/2017
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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