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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 K201662
Device Name REDUCT® Headless Compression Screw 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 Number888.3040
Classification Product Code
HWC  
Date Received06/19/2020
Decision Date 07/16/2020
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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