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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Orthopedic Stereotaxic Instrument
510(k) Number K243073
Device Name AnyPlus Navigated Instruments System
Applicant
GS Medical Co., Ltd.
90, Osongsaengmyeong 4-Ro, Osong-Eup,
Heungdeok-Gu,
Cheongju-Si,  KR
Applicant Contact Kimberley Fountain
Correspondent
GS Medical Co., Ltd.
90, Osongsaengmyeong 4-Ro, Osong-Eup,
Heungdeok-Gu,
Cheongju-Si,  KR
Correspondent Contact Barry Sands
Regulation Number882.4560
Classification Product Code
OLO  
Date Received09/27/2024
Decision Date 12/06/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
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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