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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 K221142
Device Name Kyphoplasty Balloon System
Applicant
OK Medinet Korea Co., Ltd.
418, 415 Namsung Plz., 130, Digital-Ro
Seoul,  KR 08589
Applicant Contact Kang Yoo Jin
Correspondent
Onbix Corporation
821 Samil Plz., 14, Dogok-Ro 1-Gil
Seoul,  KR 06253
Correspondent Contact Yang Ho Dong
Regulation Number888.1100
Classification Product Code
HRX  
Date Received04/19/2022
Decision Date 04/21/2023
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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