FDA 510(k) Application Details - K052763

Device Classification Name Appliance, Fixation, Spinal Intervertebral Body

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510(K) Number K052763
Device Name Appliance, Fixation, Spinal Intervertebral Body
Applicant SCIENT'X
1001 OAKWOOD BLVD
ROUND ROCK, TX 78681 US
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Contact J. D. WEBB
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Regulation Number 888.3060

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Classification Product Code KWQ
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Date Received 09/30/2005
Decision Date 11/10/2005
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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