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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Plate, Fixation, Bone
510(k) Number K200246
Device Name JPS JuniOrtho Plating System
Applicant
Orthofix Srl
Via delle Nazioni, 9
Bussolengo,  IT 37012
Applicant Contact Gianluca Ricadona
Correspondent
Wagoner Consulting LLC
PO Box 15729
Wilmington,  NC  24408
Correspondent Contact Cheryl Wagoner
Regulation Number888.3030
Classification Product Code
HRS  
Subsequent Product Code
HWC  
Date Received01/31/2020
Decision Date 05/22/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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