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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
510(k) Number K260112
Device Name QuikFix External Fixator: Knee-Spanning Pack
Applicant
Stabiliz Orthopaedics, Inc.
600 Eagleview Blvd.
Unit 300
Exton,  PA  19341
Applicant Contact Douglas Cerynik
Correspondent
MCRA
803 7th St. NW, 4th Floor
Washington,  DC  20001
Correspondent Contact Hannah Irwin
Regulation Number888.3030
Classification Product Code
KTT  
Subsequent Product Code
JDW  
Date Received01/14/2026
Decision Date 03/23/2026
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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