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 K253045
Device Name “Socko” Vimax Spinal Fixation System
Applicant
Socko Medical Co., Ltd.
10f-3, # 8, Ln. 609, Sec. 5, Chongxin Rd., Sanchong Dist
New Taipei,  TW 24159
Applicant Contact Ariel Huang
Correspondent
Socko Medical Co., Ltd.
10f-3, # 8, Ln. 609, Sec. 5, Chongxin Rd., Sanchong Dist
New Taipei,  TW 24159
Correspondent Contact Ariel Huang
Regulation Number888.3070
Classification Product Code
NKB  
Date Received09/22/2025
Decision Date 06/17/2026
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
-
-