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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Rod, Fixation, Intramedullary And Accessories
510(k) Number K092720
Device Name WRIST ARTHRODESIS NAIL 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 Number888.3020
Classification Product Code
HSB  
Date Received09/04/2009
Decision Date 06/29/2010
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
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