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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer
510(k) Number K223227
Device Name MAVEN™ Patient-Specific Instrumentation
Applicant
Paragon 28, Inc.
14445 Grasslands Dr.
Englewood,  CO  80112
Applicant Contact Greg Kowalczyk
Correspondent
Triani Consulting, LLC
14445 Grasslands Dr.
Englewood,  CO  80112
Correspondent Contact Jan Triani
Regulation Number888.3110
Classification Product Code
HSN  
Subsequent Product Code
OYK  
Date Received10/18/2022
Decision Date 11/17/2022
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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