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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 K131548
Device Name SYNTHES TROCHANTERIC FIXATION NAIL - ADVANCED SYSTEM
Applicant
SYNTHES (USA) PRODUCTS, LLC
1301 GOSHEN PKWY
WEST CHESTER,  PA  19380
Applicant Contact HEMAL MEHTA
Correspondent
SYNTHES (USA) PRODUCTS, LLC
1301 GOSHEN PKWY
WEST CHESTER,  PA  19380
Correspondent Contact HEMAL MEHTA
Regulation Number888.3020
Classification Product Code
HSB  
Date Received05/30/2013
Decision Date 02/28/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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