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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 K102090
Device Name SPINESMITH CYNCH SPINAL SYSTEM - VISUALIF INTERBODY FUSION IMPLANT SYSTEM
Applicant
SPINE SMITH PARTNERS L.P.
93 RED RIVER
AUSTIN,  TX  78701
Applicant Contact LAURA LEBOEUF
Correspondent
SPINE SMITH PARTNERS L.P.
93 RED RIVER
AUSTIN,  TX  78701
Correspondent Contact LAURA LEBOEUF
Regulation Number888.3080
Classification Product Code
OVD  
Date Received07/26/2010
Decision Date 09/30/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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