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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 K200785
Device Name Stratum™ Reduced Size Foot Plating System
Applicant
Nextremity Solutions, Inc.
210 North Buffalo Street
Warsaw,  IN  46580
Applicant Contact Adam Finley
Correspondent
Nextremity Solutions, Inc.
210 North Buffalo Street
Warsaw,  IN  46580
Correspondent Contact Adam Finley
Regulation Number888.3030
Classification Product Code
HRS  
Subsequent Product Code
HWC  
Date Received03/26/2020
Decision Date 07/27/2020
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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