FDA 510(k) Application Details - K042673

Device Classification Name Appliance, Fixation, Spinal Interlaminal

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510(K) Number K042673
Device Name Appliance, Fixation, Spinal Interlaminal
Applicant ALPHATEC/NEXMED
6110 CORTE DEL CEDRO
CARLSBAD, CA 92009 US
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Contact ELLEN A YARNALL
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Regulation Number 888.3050

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Classification Product Code KWP
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Date Received 09/29/2004
Decision Date 10/27/2004
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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