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FDA 510(k) Application Details - K132411
Device Classification Name
More FDA Info for this Device
510(K) Number
K132411
Device Name
AFFIX II SPINOUS PROCESS PLATE SYSTEM
Applicant
NUVASIVE, INCORPORATED
7475 LUSK BOULEVARD
SAN DIEGO, CA 92121 US
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Contact
OLGA LEWIS
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Regulation Number
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Classification Product Code
PEK
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More FDA Info for this Product Code
Date Received
08/02/2013
Decision Date
11/20/2013
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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