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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 K112030
Device Name SYNTHES RADIAL HEAD PROSTHESIS SYSTEM
Applicant
SYNTHES USA, LLC
1301 Goshen Parkway
West Chester,  PA  19380
Applicant Contact ANGELA F LASSANDRO
Correspondent
SYNTHES USA, LLC
1301 Goshen Parkway
West Chester,  PA  19380
Correspondent Contact ANGELA F LASSANDRO
Regulation Number888.3170
Classification Product Code
KWI  
Date Received07/15/2011
Decision Date 06/19/2012
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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