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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, Single Component
510(k) Number K080109
Device Name SYNTHES (USA) MODULAR BLADE PLATE SYSTEM
Applicant
SYNTHES (USA)
1301 GOSHEN PKWY
WEST CHESTER,  PA  19380
Applicant Contact JILL R SHERMAN
Correspondent
SYNTHES (USA)
1301 GOSHEN PKWY
WEST CHESTER,  PA  19380
Correspondent Contact JILL R SHERMAN
Regulation Number888.3030
Classification Product Code
KTW  
Date Received01/15/2008
Decision Date 03/20/2008
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
Recalls CDRH Recalls
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