FDA 510(k) Application Details - K051697

Device Classification Name Orthosis, Spondyloisthesis Spinal Fixation

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510(K) Number K051697
Device Name Orthosis, Spondyloisthesis Spinal Fixation
Applicant MEDICAL DEVICE ADVISORY DEVELOPMENT GROUP
CENTURY CENTRE
2603 MAIN STREET, SUITE 1170
IRVINE, CA 92614 US
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Contact C. STEPHEN LAWRENCE
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Regulation Number 888.3070

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Classification Product Code MNH
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Date Received 06/23/2005
Decision Date 09/21/2005
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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