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FDA 510(k) Application Details - K162313
Device Classification Name
More FDA Info for this Device
510(K) Number
K162313
Device Name
NuVasive Next Generation NVM5 System
Applicant
NUVASIVE INCORPORATED
7475 LUSK BLVD.
SAN DIEGO, CA 92121 US
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Contact
MARY ADAMS
Other 510(k) Applications for this Contact
Regulation Number
More FDA Info for this Regulation Number
Classification Product Code
PDQ
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
08/18/2016
Decision Date
03/16/2017
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
EN - Ear, Nose, & Throat
Review Advisory Committee
NE - Neurology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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