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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 K200701
Device Name Skeletal Dynamics Midshaft Humerus Plating System
Applicant
Skeletal Dynamics, Inc.
7300 N. Kendall Dr.
Suite 400
Miami,  FL  33156
Applicant Contact Diana Taylor
Correspondent
Skeletal Dynamics, Inc.
7300 N. Kendall Dr.
Suite 400
Miami,  FL  33156
Correspondent Contact Diana Taylor
Regulation Number888.3030
Classification Product Code
HRS  
Subsequent Product Code
HWC  
Date Received03/18/2020
Decision Date 05/14/2020
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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