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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Screw, Fixation, Bone
510(k) Number K220723
Device Name Hand Trauma Screw System
Applicant
Skeletal Dynamics, Inc.
7300 N. Kendall Dr.
Suite 400
Miami,  FL  33156
Applicant Contact Alexandra Rodriguez
Correspondent
Skeletal Dynamics, Inc.
7300 N. Kendall Dr.
Suite 400
Miami,  FL  33156
Correspondent Contact Alexandra Rodriguez
Regulation Number888.3040
Classification Product Code
HWC  
Date Received03/14/2022
Decision Date 05/12/2022
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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