FDA 510(k) Application Details - K193593

Device Classification Name	More FDA Info for this Device
510(K) Number	K193593
Device Name	NuVasive 3DP Interfixated ALIF System
Applicant	NuVasive, Incorporated 7475 Lusk Blvd. San Diego, CA 92121 US Other 510(k) Applications for this Company
Contact	Jessica LeBlanc 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	12/23/2019
Decision Date	03/25/2020
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