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FDA 510(k) Application Details - K062317
Device Classification Name
Orthosis, Spondyloisthesis Spinal Fixation
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510(K) Number
K062317
Device Name
Orthosis, Spondyloisthesis Spinal Fixation
Applicant
NUVASIVE, INC.
4545 TOWNE CENTRE COURT
SAN DIEGO, CA 92121 US
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Contact
LAETITIA COUSIN
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Regulation Number
888.3070
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Classification Product Code
MNH
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More FDA Info for this Product Code
Date Received
08/09/2006
Decision Date
09/01/2006
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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