FDA 510(k) Application Details - K121979

Device Classification Name Appliance, Fixation, Spinal Interlaminal

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510(K) Number K121979
Device Name Appliance, Fixation, Spinal Interlaminal
Applicant MEDICREA INTERNATIONAL
14 PORTE DU GRAND LYON
NEYRON 01700 FR
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Contact LAURA AVIRON-VIOLET
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Regulation Number 888.3050

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Classification Product Code KWP
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Date Received 07/06/2012
Decision Date 03/21/2013
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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