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Spinal Spheres

by Interbody Innovations, Llp

510(k) K062992

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 6 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 6 Oct 2026. What this means

Regulatory status

as of registry sync 6 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESU Traditional NumberK062992 Date27 Jul 2007ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 6 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  • Withdrawn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
NVR
Device Class
Class III
Advisory Committee
Unknown
FDA Decision
SESU

Overview

AI-generated summary, 18 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 Spinal Spheres Intervertebral Fusion Device is a solid-sphere interbody fusion implant designed for lumbar spinal applications. Classified as an intervertebral fusion device with bone graft, it is intended for use in spinal surgeries to promote fusion between vertebrae by providing structural support and a scaffold for bone growth.

These devices are supplied sterile and are reusable within their intended surgical setting. They are categorized under FDA 510(k) clearance (K062992) and fall under device class III. The Spinal Spheres are available in multiple sizes, as indicated by the registration numbers 1526534, 1824199, 3018094310, and 1000477302, and are intended for use in orthopedic surgical procedures. No MRI safety information is specified in the data provided.

Other devices from Interbody Innovations, Llp

Questions

AI-generated answers, 18 Sep 2026

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

  • Are the Spinal Spheres designed for use in any specific spinal regions, and if so, which ones?

    The Spinal Spheres are specifically designed for lumbar spinal applications. This means they are intended for use in the lower back region of the spine, where they provide structural support and a scaffold to promote fusion between adjacent vertebrae.

  • How are the Spinal Spheres supplied, and can they be reused in surgery?

    The Spinal Spheres are supplied sterile and are reusable within their intended surgical setting. This means they can be used multiple times in the operating room, provided proper cleaning and sterilization protocols are followed between cases.

  • What sizes are available for the Spinal Spheres, and how might this affect my selection?

    The Spinal Spheres come in multiple sizes, as indicated by the registration numbers 1526534, 1824199, 3018094310, and 1000477302. These sizes correspond to different dimensions of the spherical implants, allowing surgeons to select the appropriate fit for the patient’s anatomy during lumbar spinal fusion procedures.

  • Can the Spinal Spheres be used with MRI imaging, and if not, what should I consider instead?

    The provided data does not specify MRI safety information for the Spinal Spheres, meaning their compatibility with MRI imaging is not confirmed. If MRI follow-up is required, alternative implants with documented MRI safety should be considered to avoid potential risks.

  • What regulatory pathway was followed for the Spinal Spheres, and what does this mean for their use?

    The Spinal Spheres underwent a traditional FDA 510(k) clearance process (K062992) and are classified as Class III devices. This means they were reviewed for substantial equivalence to a predicate device and are subject to stricter regulatory oversight due to their role in spinal fusion procedures, ensuring safety and effectiveness for lumbar applications.