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 Thoracolumbosacral Pedicle Screw System
510(k) Number K261217
Device Name AnyPlus II Spinal Fixation System
Applicant
GS Medical Co., Ltd.
90, Osongsaengmyeong 4-Ro, Osong-Eup,
Heungdeok-Gu,
Cheongju-Si,  KR 28161
Applicant Contact Kim Seon Yeon
Correspondent
RQMIS, Inc.
110 Haverhill Rd.
Suite 524
Amesbury,  MA  01913
Correspondent Contact Barry Sands
Regulation Number888.3070
Classification Product Code
NKB  
Subsequent Product Codes
KWP   KWQ  
Date Received04/14/2026
Decision Date 10/02/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-