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U.S. Department of Health and Human Services

510(k) Premarket Notification
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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
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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