FDA 510(k) Application Details - K081711

Device Classification Name

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510(K) Number K081711
Device Name LUCENT MAGNUM+
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 OVD
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Date Received 06/17/2008
Decision Date 09/11/2008
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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