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Vu Apod Intervertabral Body Fusion Device

by Theken Spine, LLC

510(k) K080822

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

1 closed

Documents

Trust

Unverified

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

Overview

For the VU APOD INTERVERTABRAL BODY FUSION DEVICE, a minimally invasive orthopedic surgical intervention used to treat spinal disc herniation and degenerative conditions. This device is designed to provide stable fixation and promote healing in the spine, while minimizing recovery time and scarring. As part of the FDA's review process, this device has been deemed substantially equivalent to existing products, meeting all necessary regulatory requirements.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK080822 Date2 Jul 2008ClearedStatusActive

Recalls

1 recall · FDA

    • Terminated Z-1475-2011 FDA Unclassified (pre-2012) initiated 19 Oct 2010 on shared 510(k) K080822

    The IFU provided with the device contains incorrect information in the Indications for Use Section, stating the following: The Theken Spine Vu a"POD Intervertebral Body Fusion Device is intended for use as a stand alone implant when used with the SpinPlate provided in the set.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

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  • Withdrawn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
OVD
Device Class
Class II
Regulation
21 CFR Part 888.3080
Advisory Committee
Orthopedic
FDA Decision
SESE Substantially Equivalent

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