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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 K193377
Device Name TopLock Anchor System
Applicant
Fusion Orthopedics, LLC
4135 S. Power Rd.
Suite 110
Mesa,  AZ  85212
Applicant Contact Kolby Black
Correspondent
Fusion Orthopedics, LLC
4135 S. Power Rd.
Suite 110
Mesa,  AZ  85212
Correspondent Contact Kolby Black
Regulation Number888.3040
Classification Product Code
MBI  
Date Received12/05/2019
Decision Date 11/25/2020
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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