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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 K202019
Device Name Maven Patient-Specific Instrumentation
Applicant
Paragon 28, Inc.
14445 Grasslands Dr.
Englewood,  CO  80112
Applicant Contact Haylie Hertz
Correspondent
Musculoskeletal Clinical Regulatory Advisers, LLC
1050 K. St. NW
Suite 1000
Washington,  DC  20001
Correspondent Contact Haylie Hertz
Regulation Number888.3110
Classification Product Code
HSN  
Subsequent Product Code
OYK  
Date Received07/21/2020
Decision Date 01/14/2021
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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