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NuVasive X-Core Expandable VBR System, NuVasive X-Core Mini Cervical Expandable VBR System

by Nu Vasive, Incorporated

510(k) K193506

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Special NumberK193506 Date26 Feb 2020ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

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

Overview

AI-generated summary, 20 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The NuVasive X-Core Expandable VBR System is a vertebral body replacement device designed for spinal reconstruction. It is intended for use in the thoracolumbar spine (T1 to L5) and cervical spine (with supplemental fixation) to replace diseased or damaged vertebral bodies, restoring structural integrity and spinal alignment.

The system is supplied as an expandable, modular implant for single-use applications in surgical settings. It is regulated under FDA 510(k) clearance (K193506) and classified under product code MQP. The expandable design allows for height restoration and neural decompression, with the Mini Cervical variant intended for use at one or two cervical levels.

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