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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 K222390
Device Name Flex-Thread™ Ulna Intramedullary Nail System
Applicant
Flower Orthopedics Corporation Dba Conventus Flower
100 Witmer Rd. Suite 280
Horsham,  PA  19044
Applicant Contact Christina Rovaldi
Correspondent
Flower Orthopedics Corporation Dba Conventus Flower
100 Witmer Rd. Suite 280
Horsham,  PA  19044
Correspondent Contact Christina Rovaldi
Regulation Number888.3020
Classification Product Code
HSB  
Date Received08/08/2022
Decision Date 11/21/2022
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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