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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, Spinal Intervertebral Body
510(k) Number K031100
Device Name SYNTHES VENTROFIX MIS SYSTEM
Applicant
Synthes (Usa)
1380 Enterprise Dr.
West Chester,  PA  19380
Applicant Contact JOHN WALSH
Correspondent
Synthes (Usa)
1380 Enterprise Dr.
West Chester,  PA  19380
Correspondent Contact JOHN WALSH
Regulation Number888.3060
Classification Product Code
KWQ  
Date Received04/07/2003
Decision Date 03/04/2004
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
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