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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 K242055
Device Name Freefix Forearm Plating System
Applicant
Skeletal Dynamics, Inc.
7300 SW Kendall Dr.
Miami,  FL  33156
Applicant Contact Alexandra Rodriguez Rojas
Correspondent
Skeletal Dynamics, Inc.
7300 SW Kendall Dr.
Miami,  FL  33156
Correspondent Contact Alexandra Rodriguez Rojas
Regulation Number888.3030
Classification Product Code
HRS  
Date Received07/15/2024
Decision Date 08/01/2024
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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