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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Cement, Bone, Vertebroplasty
510(k) Number K211797
Device Name TRACKER Plus Kyphoplasty System
Applicant
GS Medical Co., Ltd.
90, Osongsaengmyeong 4-Ro, Osong-Eup,
Heungdeok-Gu,
Cheongju-Si,  KR 28161
Applicant Contact Sam Camp
Correspondent
RQMIS, Inc.
110 Haverhill Rd.
Suite 524
Amesbury,  MA  01913
Correspondent Contact Barry Sands
Regulation Number888.3027
Classification Product Code
NDN  
Subsequent Product Code
HRX  
Date Received06/10/2021
Decision Date 10/28/2021
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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