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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 K212030
Device Name Flex-Thread™ Distal Fibula lntramedullary Nail System
Applicant
Flower Orthopedics Corporation Dba Conventus Flower
100 Witmer Rd.
Horsham,  PA  19044
Applicant Contact Amanda Pentecost
Correspondent
Flower Orthopedics Corporation Dba Conventus Flower
100 Witmer Rd.
Horsham,  PA  19044
Correspondent Contact Amanda Pentecost
Regulation Number888.3020
Classification Product Code
HSB  
Date Received06/29/2021
Decision Date 07/23/2021
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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