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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Screw, Fixation, Bone
510(k) Number K201430
Device Name InFrame™ Cannulated Fixation System
Applicant
Exsomed Corp.
135 Columbia
Aliso Viejo,  CA  92656
Applicant Contact Jung Chang
Correspondent
Regulatory and Quality Solutions, LLC
2790 Mosside Blvd., Suite 800
Monroeville,,  PA  15146
Correspondent Contact Patricia Kontoudis
Regulation Number888.3040
Classification Product Code
HWC  
Date Received06/01/2020
Decision Date 06/20/2020
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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