Home / 510(k) Clearances / K231735

510(k) K231735

NuVasive CoRoent Small Interbody System; NuVasive CoRoent Small Contoured Interbody System; NuVasive CoRoent Small Interlock System; NuVasive CoRoent Small Interlock II System; NuVasive CoRoent Small Ti-C System; NuVasive Cohere Cervical Interbody System by Nu Vasive, Incorporated — Product Code ODP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 11, 2023
Date Received
June 14, 2023
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

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

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

Other clearances by Nu Vasive, Incorporated

  • 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)
  • K210574 — NuVasive Pulse System (July 29, 2021)

Other clearances for product code ODP

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  • K254061 — Curiteva Porous PEEK Cervical Interbody Fusion System (January 15, 2026)
  • K252219 — Cervical Interbody and VBR Fusion System (January 14, 2026)
  • K252711 — Advantage-C™ Ti3D Cervical Interbody Fusion Device (January 8, 2026)
  • K252894 — aprevo® cervical interbody system (January 6, 2026)
  • K252781 — MSFX MIKRON PEEK CAGES (December 19, 2025)
  • K250764 — SpineLinc Anterior Cervical Implant System (December 5, 2025)
  • K250769 — Dakota LP System (November 24, 2025)
  • K252686 — EffortMed PEEK Cages & Corpectomy Cages (November 21, 2025)