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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Prosthesis, Elbow, Hemi-, Radial, Polymer
510(k) Number K172688
Device Name Align Radial Head System
Applicant
Skeletal Dynamics, LLC
8905 SW 87 Ave., Suite 201
Miami,  FL  33176
Applicant Contact Ana M. Escagedo
Correspondent
Skeletal Dynamics, LLC
8905 SW 87 Ave., Suite 201
Miami,  FL  33176
Correspondent Contact Ana M. Escagedo
Regulation Number888.3170
Classification Product Code
KWI  
Date Received09/06/2017
Decision Date 12/22/2017
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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