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510(k) K201820

NuVasive Thoracolumbar Interbody Systems: CoRoent Thoracolumbar System, CoRoent XL Interfixated System, Brigade Standalone System and Brigade Hyperlordotic System, Brigade Lateral System, BASE Interfixated Titanium System, Coalesce Thoracolumbar Interbody Fusion System, Cohere Thoracolumbar Interbody System, Modulus XLIF Interbody System, Modulus TLIF Interbody System, 3DP Interfixated ALIF System by Nu Vasive, Incorporated — Product Code MAX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 25, 2020
Date Received
July 1, 2020
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Intervertebral Fusion Device With Bone Graft, Lumbar
Device Class
Class II
Regulation Number
888.3080
Review Panel
OR
Submission Type

Intended to stabilize spinal segment to promote fusion in order to restrict motion and decrease pain using bone graft.

Other clearances by Nu Vasive, Incorporated

  • K231735 — NuVasive CoRoent Small Interbody System; NuVasive CoRoent Small Contoured Interb (July 11, 2023)
  • K230894 — NuVasive Modulus ALIF System (June 16, 2023)
  • K230989 — Rod Registration Frame (May 5, 2023)
  • K223181 — NuVasive Reline System (January 11, 2023)
  • K221751 — NuVasive Cohere ALIF System Intervertebral Body Fusion Device (October 21, 2022)
  • K221388 — NuVasive Reline Cervical System (September 9, 2022)
  • K220478 — NuVasive MOD-EX XLIF Interbody System, NuVasive MOD-EX XLIF Plated 2.0 Interbody (June 21, 2022)
  • K213654 — NuVasive Reline Cervical System (February 23, 2022)
  • K203714 — NuVasive Thoracolumbar Interbody Systems: NuVasive CoRoent Thoracolumbar System, (December 23, 2021)
  • K212446 — NuVasive Anterior Cervical Plate Systems (November 3, 2021)

Other clearances for product code MAX

  • K254017 — SWINGO-3D Lumbar Cage System (February 26, 2026)
  • K253583 — LUX Expandable Lumbar Interbody System (February 23, 2026)
  • K250773 — Luna® Ti Interbody Fusion System (February 4, 2026)
  • K253748 — Life Spine ProLift & ProLift Lateral and ProLift Lateral Fixated Expandable Spac (January 23, 2026)
  • K253266 — Titanium Interbody System (January 8, 2026)
  • K253577 — IB3D™ PL Spinal System (A24000000 / IB3D Universal Implant Inserter) (December 19, 2025)
  • K252610 — ZSFab Lumbar Interbody System (November 25, 2025)
  • K252351 — UniSpace® TPLIF Cage (October 28, 2025)
  • K253377 — Expandable Titanium PLIF/TLIF System (October 24, 2025)
  • K251479 — Mobarn 80:20 Lumbar Interbody Fusion System (Posterior Lumbar Interbody Fusion C (September 18, 2025)