FDA 510(k) Application Details - K181386

Device Classification Name

  More FDA Info for this Device
510(K) Number K181386
Device Name NuVasive Brigade Lateral System
Applicant NuVasive, Incorporated
7475 Lusk Blvd.
San Diego, CA 92121 US
Other 510(k) Applications for this Company
Contact Jessica Silverman
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 05/25/2018
Decision Date 08/24/2018
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



Search | Companies | Product Codes | Device Names | Contacts | Applications | Decisions | Contact