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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Rod, Fixation, Intramedullary And Accessories
510(k) Number K202858
Device Name Flex-ThreadTM Distal Fibula Intramedullary Nail System
Applicant
Conventus Orthopaedics, LLC
10200 73rd Ave. N.
Suite 122
Maple Grove,  MN  55369
Applicant Contact Amanda Pentecost
Correspondent
Conventus Orthopaedics, LLC
10200 73rd Ave. N.
Suite 122
Maple Grove,  MN  55369
Correspondent Contact Amanda Pentecost
Regulation Number888.3020
Classification Product Code
HSB  
Date Received09/28/2020
Decision Date 01/22/2021
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
Recalls CDRH Recalls
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