FDA 510(k) Application Details - K071833

Device Classification Name

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510(K) Number K071833
Device Name MOSAIC DEVICES
Applicant SPINAL ELEMENTS, INC.
2744 LOKER AVE. W. SUITE 100
CARLSBAD, CA 92008 US
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Contact KERRI DIMARTINO
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Regulation Number

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Classification Product Code OVE
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Date Received 07/03/2007
Decision Date 10/23/2007
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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