510(k) K123045

BRIGADE STANDALONE SYSTEM by Nuvasive, Inc. — Product Code OVD

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: April 16, 2013
Date Received: October 1, 2012
Clearance Type: Special
Expedited Review: No
Third Party Review: No

Device Classification

Device Name: Intervertebral Fusion Device With Integrated Fixation, Lumbar
Device Class: Class II
Regulation Number: 888.3080
Review Panel: OR
Submission Type

Intended to stabilize lumbar spinal segment to promote fusion in order to restrict motion and decrease pain using bone graft with or without supplemental fixation.

Other clearances by Nuvasive, Inc.

K233706 — Bendini Cloud Application (August 2, 2024)
K240507 — NuVasive AttraX Scaffold (March 20, 2024)
K223731 — NuVasive Modulus-C Interbody System (January 12, 2023)
K211757 — Simplify Disc (August 20, 2021)
K173117 — NuVasive® VersaTie System (December 7, 2017)
K141665 — NuVasive CoRoent System (March 13, 2015)
K142205 — NuVasive X-CORE(R) Expandable VBR System (February 20, 2015)
K141968 — NUVASIVE NVM5 SYSTEM (November 14, 2014)
K140319 — COROENT TI-C SYSTEM (October 9, 2014)
K140162 — AP EXPANDABLE XLIF SYSTEM (July 2, 2014)

Other clearances for product code OVD

K253559 — Ventana A Anterior Lumbar Interbody System (February 25, 2026)
K251829 — DeGen Medical Patient Specific Implant (PSI) System (December 8, 2025)
K251575 — IdentiTi II ALIF Standalone Interbody System; Transcend ALIF Standalone Interb (September 3, 2025)
K250072 — CONDUIT SYNFIX Evolution Secured Spacer System (July 10, 2025)
K251644 — ProAM ALIF System (June 24, 2025)
K250845 — Curiteva Porous PEEK Standalone ALIF System (June 18, 2025)
K251459 — OneLIF Interbody Fusion System (June 12, 2025)
K243934 — Stable-L Lumbar Interbody System (April 30, 2025)
K243386 — Ventris Intervertebral Body Fusion Device (April 22, 2025)
K250603 — AxTiHA® Stand-Alone ALIF System (March 24, 2025)