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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 K260362
Device Name QUATTRO Spinal system (Open Configuration); QUATTRO-GADGET Spinal system (MIS Configuration)
Applicant
MANTIZ Co., Ltd.
423-15, Hyeoksin-Daero
Daegu,  KR 41701
Applicant Contact Jay Kim
Correspondent
MANTIZ Co., Ltd.
423-15, Hyeoksin-Daero
Daegu,  KR 41701
Correspondent Contact Jay Kim
Regulation Number888.3070
Classification Product Code
NKB  
Date Received02/04/2026
Decision Date 07/24/2026
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
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