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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Shoulder Prosthesis, Reverse Configuration
510(k) Number K103251
Device Name DUOCENTRIC REVERSED
Applicant
Aston Medical
577 N. Hope Ave.
Santa Barbara,  CA  93110
Applicant Contact CATHERINE GLOSTER
Correspondent
Aston Medical
577 N. Hope Ave.
Santa Barbara,  CA  93110
Correspondent Contact CATHERINE GLOSTER
Regulation Number888.3660
Classification Product Code
PHX  
Date Received11/03/2010
Decision Date 10/28/2011
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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