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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 K111891
Device Name SYNTHES BRAINLAB TRAUMA COMPATIBLE INSTRUMENTS
Applicant
SYNTHES (USA) PRODUCTS LLC
1303 GOSHEN PARKWAY
WEST CHESTER,  PA  19380
Applicant Contact CHRISTOPHER HACK
Correspondent
SYNTHES (USA) PRODUCTS LLC
1303 GOSHEN PARKWAY
WEST CHESTER,  PA  19380
Correspondent Contact CHRISTOPHER HACK
Regulation Number888.3020
Classification Product Code
HSB  
Subsequent Product Codes
HRS   KTT  
Date Received07/05/2011
Decision Date 11/28/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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