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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 K111326
Device Name OSTEOWEDGE OPENING WEDGE BONE LOCKING SYSTEM
Applicant
Graham Medical Technologies, LLC
611 W. 5th St. Third Floor
Austin,  TX  78701
Applicant Contact JULIE POWELL
Correspondent
Graham Medical Technologies, LLC
611 W. 5th St. Third Floor
Austin,  TX  78701
Correspondent Contact JULIE POWELL
Regulation Number888.3030
Classification Product Code
HRS  
Subsequent Product Code
HWC  
Date Received05/11/2011
Decision Date 07/06/2011
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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