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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
Recalls CDRH Recalls
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