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FDA 510(k) Application Details - K170592
Device Classification Name
More FDA Info for this Device
510(K) Number
K170592
Device Name
NuVasive BASE Interfixated Titanium System
Applicant
NuVasive, Incorporated
7475 Lusk Blvd.
San Diego, CA 92121 US
Other 510(k) Applications for this Company
Contact
Cynthia Adams
Other 510(k) Applications for this Contact
Regulation Number
More FDA Info for this Regulation Number
Classification Product Code
OVD
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
02/28/2017
Decision Date
04/26/2017
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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