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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Pin, Fixation, Smooth
510(k) Number K262722
Device Name Primal K-Wire (P99-193-1410)
Applicant
Paragon 28, Inc.
14445 Grasslands Dr.
Centennial,  CO  80112
Applicant Contact Daniel Nelson
Correspondent
Paragon 28, Inc.
14445 Grasslands Dr.
Englewood,  CO  80112
Correspondent Contact Dan Nelson
Regulation Number888.3040
Classification Product Code
HTY  
Date Received07/31/2026
Decision Date 08/28/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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