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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 K211086
Device Name The Progen™ Trochanteric Nail System
Applicant
Ortho Development Corporation
12187 S. Business Park Dr.
Draper,  UT  84020
Applicant Contact Divya Palan
Correspondent
Ortho Development Corporation
12187 S. Business Park Dr.
Draper,  UT  84020
Correspondent Contact Drew Weaver
Regulation Number888.3020
Classification Product Code
HSB  
Subsequent Product Code
JDS  
Date Received04/12/2021
Decision Date 12/21/2021
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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