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FDA 510(k) Application Details - K051697
Device Classification Name
Orthosis, Spondyloisthesis Spinal Fixation
More FDA Info for this Device
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
Other 510(k) Applications for this Contact
Regulation Number
888.3070
More FDA Info for this Regulation Number
Classification Product Code
MNH
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More FDA Info for this Product Code
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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