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NuVasive CoRoent System

by Nuvasive, Inc. United States 510(k)

510(k) K043405

Product code MQP

Overview

The NuVasive CoRoent System is a polymeric interbody fusion cage designed for intervertebral body fusion of the spine in skeletally mature patients. It provides a structural scaffold that can be packed with autogenous or allogeneic cancellous or corticocancellous bone graft to promote spinal fusion.

The system has received FDA 510(k) clearance (Traditional, Substantially Equivalent) under product code MQP and is listed with K-number K043405. It is supplied as a complete implant package intended for use with supplemental internal spinal fixation systems, and is referenced in orthopedic advisory committee filings. No specific sterility, single‑use, or MRI safety information is provided in the available data.

Summary written by AI from registry data, 28 Sep 2026.Not verified

About this summary

This description and any FAQs on this page were generated automatically and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK043405 Date7 Feb 2005ClearedStatusActive

Coverage

1 jurisdiction

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of America
  • Active
  • Not covered

United States — FDA 510(k) Active

Recalls

1 recall · FDA

    • Terminated Z-2356-2010 FDA Unclassified (pre-2012) initiated 1 Feb 2010 via K043405, on the same 510(k)

    Defects include, but not limited to: Not sterile, not properly labeled, drugs and swabs may be ineffective, and catheter tips may break in patients.

Recalls marked "via" name another device cleared under the same FDA submission as this one.

Specification

510(k) · synced 22 Oct 2026

510(k) Number
FDA Product Code
MQP
Device Class
Class II
Regulation
21 CFR Part 888.3060
Advisory Committee
Orthopedic
FDA Decision
SESE Substantially Equivalent

Other devices from Nuvasive, Inc.

See all devices from Nuvasive, Inc. →

Questions

  • What clinical purpose does the NuVasive CoRoent System serve?

    It provides a structural scaffold within the intervertebral space to facilitate bone growth and achieve solid spinal fusion in skeletally mature patients. By being filled with autogenous or allogeneic cancellous or corticocancellous graft, it promotes the biological environment needed for successful fusion.

  • How is the CoRoent System supplied and what additional components are required?

    The device is delivered as a complete implant package intended for use together with supplemental internal spinal fixation systems, such as rods or screws. The cage itself does not include fixation hardware, so surgeons must select compatible fixation devices to secure the construct.

  • Is the CoRoent System a single‑use product and what sterility information is available?

    The available data do not specify sterility status or single‑use labeling. Because it is supplied as a sterile implant package for surgical implantation, it is generally treated as a single‑use device, but users should verify the manufacturer’s labeling and institutional policies before reuse.

  • What regulatory pathway did the CoRoent System follow for market entry?

    The system received traditional FDA 510(k) clearance as substantially equivalent to a predicate device, listed under product code MQP with K‑number K043405. This pathway indicates that the device was found to have the same intended use and technological characteristics as an already cleared device.

Properties & raw data

Show properties, registry sources and raw records

Sources (1)

  • FDA 510(k) K043405 24 fields · synced 22 Oct 2026