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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 K051678
Device Name SYNTHES HINDFOOT ARTHRODESIS NAIL SYSTEM
Applicant
SYNTHES (USA)
1302 WRIGHTS LANE EAST
WEST CHESTER,  PA  19380
Applicant Contact SHERI L MUSGNUNG
Correspondent
SYNTHES (USA)
1302 WRIGHTS LANE EAST
WEST CHESTER,  PA  19380
Correspondent Contact SHERI L MUSGNUNG
Regulation Number888.3020
Classification Product Code
HSB  
Date Received06/23/2005
Decision Date 09/21/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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