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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 K092721
Device Name ALIGN RADIAL HEAD SYSTEM
Applicant
Skeletal Dynamics, LLC
80 Sheldon Technology Center
Shelton,  CT  06484
Applicant Contact JOSEPH AZARY
Correspondent
Skeletal Dynamics, LLC
80 Sheldon Technology Center
Shelton,  CT  06484
Correspondent Contact JOSEPH AZARY
Regulation Number888.3170
Classification Product Code
KWI  
Date Received09/04/2009
Decision Date 08/03/2010
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
Recalls CDRH Recalls
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