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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Staple, Fixation, Bone
510(k) Number K261121
Device Name Megalodon Dynamic Compression System
Applicant
Paragon 28, Inc.
14445 Grasslands Dr.
Centennial,  CO  80112
Applicant Contact Brittanie Dogue
Correspondent
Paragon 28, Inc.
14445 Grasslands Dr.
Centennial,  CO  80112
Correspondent Contact Brittanie Dogue
Regulation Number888.3030
Classification Product Code
JDR  
Date Received04/03/2026
Decision Date 08/06/2026
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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