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T2 XVBR Spinal System

by Medtronic Sofamor Danek, Inc. 2 variants

510(k) K071033

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 · Traditional NumberK071033 Date14 Aug 2007ClearedStatusActive

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  • Withdrawn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
FDA applicant
Medtronic Sofamor Danek
Device class
Class II
Regulation
21 CFR Part 888.3060
Advisory committee
Orthopedic
FDA decision
SESE Substantially Equivalent

Overview

AI-generated summary, 1 Oct 2026

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

The T2 XVBR Spinal System is a vertebral body replacement device classified under product code MQP. It is designed as a spinal implant intended for use in the thoracolumbar spine (T1-L5) to replace a collapsed, damaged, or unstable vertebral body caused by tumor or trauma, such as a fracture. The system provides structural support and stability to the spine in these compromised regions.

This device is supplied as a reusable surgical implant and is intended for use in an operating room setting. It is regulated under FDA 510(k) clearance (K071033) and falls under Class II – Special Controls for spinal vertebral body replacement. The system is not described as single-use or MRI-safe in the available data, and no specific sterility or storage conditions are mentioned beyond standard surgical implant protocols.

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Questions

AI-generated answers, 1 Oct 2026

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

  • What is the T2 XVBR Spinal System used for?

    The T2 XVBR Spinal System is designed to replace a collapsed, damaged, or unstable vertebral body in the thoracolumbar spine (T1-L5) caused by trauma—such as fractures—or tumors. It provides structural support and stability to restore spinal integrity in compromised regions.

  • Is the T2 XVBR Spinal System single-use or reusable?

    The T2 XVBR Spinal System is supplied as a reusable surgical implant. It is intended for use in an operating room setting and is not described as single-use in the available data.

  • What regulatory clearance does the T2 XVBR Spinal System have?

    The T2 XVBR Spinal System holds FDA 510(k) clearance (K071033) under product code MQP, classified as a spinal vertebral body replacement device. It falls under Class II – Special Controls for spinal implants.

  • What spinal regions does the T2 XVBR Spinal System target?

    This system is specifically designed for the thoracolumbar spine, covering vertebrae from T1 (first thoracic) to L5 (fifth lumbar). It is not intended for cervical or sacral regions.

  • Are there any special storage requirements for the T2 XVBR Spinal System?

    The available data does not specify unique sterility or storage conditions beyond standard surgical implant protocols. It should be handled according to general operating room practices for reusable orthopedic implants.