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FDA 510(k) Application Details - K133052
Device Classification Name
More FDA Info for this Device
510(K) Number
K133052
Device Name
AFFIX(R) NEXT GEN SPINOUS PROCESS PLATE SYSTEM
Applicant
NUVASIVE, INC.
7475 LUSK BLVD
SAN DIEGO, CA 92121 US
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Contact
OLGA LEWIS
Other 510(k) Applications for this Contact
Regulation Number
More FDA Info for this Regulation Number
Classification Product Code
PEK
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
09/27/2013
Decision Date
12/20/2013
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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