FDA 510(k) Application Details - K120515

Device Classification Name Appliance, Fixation, Spinal Intervertebral Body

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510(K) Number K120515
Device Name Appliance, Fixation, Spinal Intervertebral Body
Applicant NEUROSTRUCTURES, LLC
4628 NORTHPARK DR
COLORADO SPRINGS, CO 80918 US
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Contact MEREDITH MAY
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Regulation Number 888.3060

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Classification Product Code KWQ
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Date Received 02/21/2012
Decision Date 05/23/2012
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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