FDA 510(k) Application Details - K990845

Device Classification Name Appliance, Fixation, Spinal Interlaminal

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510(K) Number K990845
Device Name Appliance, Fixation, Spinal Interlaminal
Applicant ADVANCED SPINE FIXATION SYSTEMS, INC.
3722 AVE. SAUSALITO
IRVINE, CA 92606 US
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Contact GREG HOLLAND
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Regulation Number 888.3050

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Classification Product Code KWP
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Date Received 03/15/1999
Decision Date 04/13/1999
Decision SESE - SUBST EQUIV
Classification Advisory Committee OR - Orthopedic
Review Advisory Committee OR - Orthopedic
Statement / Summary / Purged Status Statement
Type Special
Reviewed By Third Party N
Expedited Review



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