FDA 510(k) Application Details - K024326

Device Classification Name Appliance, Fixation, Spinal Intervertebral Body

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510(K) Number K024326
Device Name Appliance, Fixation, Spinal Intervertebral Body
Applicant SPINAL CONCEPTS, INC.
5301 RIATA PARK COURT
BLDG F
AUSTIN, TX 78727 US
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Contact LISA PETERSON
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Regulation Number 888.3060

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Classification Product Code KWQ
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Date Received 12/26/2002
Decision Date 01/23/2003
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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