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Galileo Vertebral Body Replacement Device

by Bright Spine 510(k)

Active United States

510(k) K221542

Overview

The Galileo Vertebral Body Replacement Device is a spinal vertebral body replacement device for cervical use. It is designed to replace damaged or diseased vertebral bodies in the cervical spine to restore spinal alignment and stability.

The device is supplied sterile and intended for single-use. It is regulated as a Class II medical device under FDA 510(k) clearance (K221542) and is authorized for distribution in the United States. Storage and handling should follow manufacturer guidelines for sterile single-use implants.

AI-generated from registry data, 23 Sep 2026.Not verified by deviCERTS or the manufacturer

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Special NumberK221542 Date13 Jan 2023ClearedStatusActive

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 AmericaUnited States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

Specification

510(k)

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

Other devices from Bright Spine

Questions

  • What is the Galileo Vertebral Body Replacement Device used for?

    The Galileo Vertebral Body Replacement Device is used to replace damaged or diseased vertebral bodies in the cervical spine to restore spinal alignment and stability following injury or degeneration.

  • Is the Galileo Vertebral Body Replacement Device sterile and single-use?

    Yes, the device is supplied sterile and intended for single-use only, as specified in the manufacturer’s guidelines for handling and implantation of sterile spinal implants.

  • What regulatory pathway was used for the Galileo Vertebral Body Replacement Device?

    The device received FDA 510(k) clearance (K221542) as a Class II medical device, determined to be substantially equivalent to a predicate device for cervical vertebral body replacement.

  • Who manufactures the Galileo Vertebral Body Replacement Device and where is it authorized for distribution?

    The Galileo Vertebral Body Replacement Device is manufactured by Bright Spine and is authorized for distribution in the United States under FDA 510(k) clearance K221542.