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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 K221084
Device Name Dyna Locking Trochanteric Nail™
Applicant
Innosys
20, Sandan-Ro 76 Beon-Gil(Rd)
Uijeongbu-Si,  KR 11781
Applicant Contact Yu-jin Kang
Correspondent
Innosys Co., Ltd.
20, Sandan-Ro 76 Beon-Gil(Rd)
Uijeongbu-Si,  KR 11781
Correspondent Contact Yu-jin Kang
Regulation Number888.3020
Classification Product Code
HSB  
Subsequent Product Code
HTY  
Date Received04/13/2022
Decision Date 03/03/2023
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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