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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Intervertebral Fusion Device With Bone Graft, Lumbar
510(k) Number K103814
Device Name PEZO INTERBODY CAGES SYSTEM
Applicant
Ulrich GmbH & Co. KG
612 Trade Center Blvd.
Chesterfield,  MO  63005
Applicant Contact HANS STOVER
Correspondent
Ulrich GmbH & Co. KG
612 Trade Center Blvd.
Chesterfield,  MO  63005
Correspondent Contact HANS STOVER
Regulation Number888.3080
Classification Product Code
MAX  
Date Received12/29/2010
Decision Date 03/17/2011
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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