FDA 510(k) Application Details - K102090

Device Classification Name

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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 US
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Contact LAURA LEBOEUF
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Regulation Number

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Classification Product Code OVD
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Date Received 07/26/2010
Decision Date 09/30/2010
Decision SESE - SUBST EQUIV
Classification Advisory Committee OR - Orthopedic
Review Advisory Committee OR - Orthopedic
Statement / Summary / Purged Status Summary
Type Special
Reviewed By Third Party N
Expedited Review



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