FDA 510(k) Application Details - K051716

Device Classification Name Appliance, Fixation, Spinal Interlaminal

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510(K) Number K051716
Device Name Appliance, Fixation, Spinal Interlaminal
Applicant VERTEBRON, INC.
400 LONG BEACH BLVD.
STRATFORD, CT 06615 US
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Contact LUIS NESPRIDO
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Regulation Number 888.3050

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Classification Product Code KWP
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Date Received 06/27/2005
Decision Date 09/07/2005
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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