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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Fastener, Fixation, Nondegradable, Soft Tissue
510(k) Number K253618
Device Name QuadLock™ Fixation System
Applicant
Abanza Tecnomed S.L
Calle Nueva, 29
Mutilva,  ES 31192
Applicant Contact Andrea Larranaga
Correspondent
Precision Life Science Partners
300 Creek View Rd.
Newark,  DE  19711
Correspondent Contact Jessica Czamanski
Regulation Number888.3040
Classification Product Code
MBI  
Date Received11/18/2025
Decision Date 01/06/2026
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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