Home / 510(k) Clearances / K193506

510(k) K193506

NuVasive X-Core Expandable VBR System, NuVasive X-Core Mini Cervical Expandable VBR System by Nu Vasive, Incorporated — Product Code MQP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 26, 2020
Date Received
December 18, 2019
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Spinal Vertebral Body Replacement Device
Device Class
Class II
Regulation Number
888.3060
Review Panel
OR
Submission Type

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 MQP

  • K253158 — VyBrate™ VBR System (January 7, 2026)
  • K241468 — Vertiwedge® Intraosseous System (November 7, 2024)
  • K232790 — KONG®-TL VBR System and KONG® C VBR System (April 4, 2024)
  • K233359 — DOMINION Expandable Corpectomy System (March 8, 2024)
  • K231134 — VerteLoc Spinal System (February 13, 2024)
  • K232173 — Ascend VBR System, Ascend NanoTec VBR System (October 6, 2023)
  • K211892 — ArtFx Corpectomy Cages (Espinax and Distractania Corpectomy Cages) (October 6, 2022)
  • K202637 — F3D Corpectomy System (December 23, 2020)
  • K200235 — KONG-TL VBR System, KONG-C VBR System (May 29, 2020)
  • K192117 — Small VBR™ (November 1, 2019)