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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Appliance, Fixation, Spinal Intervertebral Body
510(k) Number K161641
Device Name LOSPA IS ACP System
Applicant
Corentec Co., Ltd.
12, Yeongsanhong 1-Gil, Ipjang-Myeon, Seobuk Gu
Cheonan,  KR 31056
Applicant Contact J.S. DANIEL
Correspondent
Corentec Co., Ltd.
8f Chungho Tower, 483, Gangnam-Daero, Seocho Gu
Seoul,  KR 06541
Correspondent Contact J.S. DANIEL
Regulation Number888.3060
Classification Product Code
KWQ  
Date Received06/14/2016
Decision Date 01/05/2017
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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