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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 K151268
Device Name SPINAUT-V, SPINAUT-S, SPINAUT-I
Applicant
Imedicom Co., Ltd.
#612, 172, Ls-Ro
Gunpo-Si,  KR 435-824
Applicant Contact BONGGU HA
Correspondent
LK Consulting Group USA, Inc.
2651 E. Chapman Ave., Suite 110
Fullerton,  CA  92831
Correspondent Contact PRISCILLA CHUNG
Regulation Number888.1100
Classification Product Code
HRX  
Date Received05/13/2015
Decision Date 03/16/2016
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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