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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 Integrated Fixation, Lumbar
510(k) Number K122168
Device Name VISUALIF CHALLENGING ACCESS PLATE
Applicant
Spine Smith Partners L.P.
93 Red River
Austin,  TX  78701
Applicant Contact CLIFTON NAIVAR
Correspondent
Spine Smith Partners L.P.
93 Red River
Austin,  TX  78701
Correspondent Contact CLIFTON NAIVAR
Regulation Number888.3080
Classification Product Code
OVD  
Date Received07/23/2012
Decision Date 10/11/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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