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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Plate, Fixation, Bone
510(k) Number K061940
Device Name SYNTHES LCP ANKLE ARTHRODESIS PLATES
Applicant
Synthes (Usa)
1301 Goshen Pkwy.
19380,  PA  19380
Applicant Contact SHERI L MUSGNUNG
Correspondent
Synthes (Usa)
1301 Goshen Pkwy.
19380,  PA  19380
Correspondent Contact SHERI L MUSGNUNG
Regulation Number888.3030
Classification Product Code
HRS  
Date Received07/10/2006
Decision Date 09/08/2006
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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