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FDA 510(k) Application Details - K190418
Device Classification Name
More FDA Info for this Device
510(K) Number
K190418
Device Name
NuVasive« VersaTie« System
Applicant
NuVasive, Incorporated
7475 Lusk Blvd.
San Diego, CA 92121 US
Other 510(k) Applications for this Company
Contact
Joseph De La Rosa
Other 510(k) Applications for this Contact
Regulation Number
More FDA Info for this Regulation Number
Classification Product Code
OWI
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
02/21/2019
Decision Date
03/21/2019
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
OR - Orthopedic
Review Advisory Committee
OR - Orthopedic
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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