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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name plate, fixation, bone
510(k) Number K073115
Device Name ORTHOMESH
Applicant
SYNTHES (USA)
1230 WILSON DRIVE
WEST CHESTER,  PA  19380
Applicant Contact JEFFREY L DOW
Correspondent
SYNTHES (USA)
1230 WILSON DRIVE
WEST CHESTER,  PA  19380
Correspondent Contact JEFFREY L DOW
Regulation Number888.3030
Classification Product Code
HRS  
Subsequent Product Code
HWC  
Date Received11/05/2007
Decision Date 07/15/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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