Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

510(k) Premarket Notification
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back To Search Results
Device Classification Name cement, bone, vertebroplasty
510(k) Number K192335
Device Name TRACKER Kyphoplasty System
Applicant
GS Medical Co., Ltd.
90, Osongsaengmyeong 4-ro
Osong-eup, Cheongwon-gun,  KR 363-951
Applicant Contact Andrea Watt
Correspondent
RQMIS, Inc.
110 Haverhill Road, Suite 526
Amesbury,  MA  01860
Correspondent Contact Barry Sands
Regulation Number888.3027
Classification Product Code
NDN  
Subsequent Product Code
HRX  
Date Received08/28/2019
Decision Date 12/04/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-