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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name appliance, fixation, nail/blade/plate combination, multiple component
510(k) Number K122455
Device Name SYNTHES SMALL EXTERNAL FIXATION SYSTEM, SYNTHES LARGE EXTERNAL FIXATION SYSTEM
Applicant
SYNTHES
1301 Goshen Parkway
West Chester,  PA  19380
Applicant Contact ANGELA F LASSANDRO
Correspondent
SYNTHES
1301 Goshen Parkway
West Chester,  PA  19380
Correspondent Contact ANGELA F LASSANDRO
Regulation Number888.3030
Classification Product Code
KTT  
Date Received08/13/2012
Decision Date 04/11/2013
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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