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FDA 510(k) Application Details - K123307
Device Classification Name
More FDA Info for this Device
510(K) Number
K123307
Device Name
NUVASIVE NVM5 SYSTEM
Applicant
NUVASIVE, INC.
7475 LUSK BLVD
SAN DIEGO, CA 92121 US
Other 510(k) Applications for this Company
Contact
Sheila Bruschi
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
10/24/2012
Decision Date
04/23/2013
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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