FDA 510(k) Application Details - K040003

Device Classification Name Appliance, Fixation, Spinal Intervertebral Body

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510(K) Number K040003
Device Name Appliance, Fixation, Spinal Intervertebral Body
Applicant VERTEBRON, INC.
136 ALBERT AVENUE
STRATFORD, CT 06614 US
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Contact BRUCE KHALILI
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Regulation Number 888.3060

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Classification Product Code KWQ
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Date Received 01/02/2004
Decision Date 03/26/2004
Decision SESE - SUBST EQUIV
Classification Advisory Committee OR - Orthopedic
Review Advisory Committee OR - Orthopedic
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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