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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
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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