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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 K202764
Device Name Ortho Solutions Plating System
Applicant
Ortho Solutions UK , Ltd.
West Station Business Park, Spital Rd.
Maldon,  GB CMF 6FF
Applicant Contact Andy Leither
Correspondent
Ortho Solutions UK , Ltd.
West Station Business Park, Spital Rd.
Maldon,  GB CMF 6FF
Correspondent Contact Andy Leither
Regulation Number888.3030
Classification Product Code
HRS  
Subsequent Product Codes
HTN   HWC  
Date Received09/21/2020
Decision Date 11/20/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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