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PEEK Spinal Spheres

by Interbody Innovations, Llp

510(k) K073105

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 Special NumberK073105 Date3 Jan 2008ClearedStatusActive

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  • Withdrawn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 PEEK Spinal Spheres are classified as Intervertebral Fusion Devices With Bone Graft, Solid-Sphere, Lumbar, per FDA nomenclature. These devices are designed to facilitate spinal fusion by providing structural support and promoting bone growth between vertebrae in the lumbar region, helping restore stability and alignment in the spine.

These spheres are intended for surgical use in spinal fusion procedures and are supplied as a Class III medical device under FDA 510(k) clearance (K073105). Manufactured from polyether ether ketone (PEEK), they are reusable and require sterilization before use. The device is regulated under the Special 510(k) review pathway and is distributed by Interbody Innovations, LLP, based in Round Rock, TX.

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.

  • What is the primary purpose of the PEEK Spinal Spheres in spinal surgery?

    The PEEK Spinal Spheres are designed to facilitate spinal fusion in the lumbar region by providing structural support and promoting bone growth between vertebrae. This helps restore stability and proper alignment in the spine during surgical procedures.

  • Are the PEEK Spinal Spheres intended for single-use or can they be reused?

    The PEEK Spinal Spheres are reusable and require sterilization before each use, as they are manufactured from polyether ether ketone (PEEK). This allows for multiple applications after proper sterilization procedures are followed.

  • How are these devices regulated and what pathway was used for FDA clearance?

    The PEEK Spinal Spheres are classified as a Class III medical device under the FDA and were cleared through the Special 510(k) review pathway. The clearance number is K073105, and the device is distributed by Interbody Innovations, LLP, based in Round Rock, TX.

  • What material are the PEEK Spinal Spheres made from, and does this affect their durability?

    The PEEK Spinal Spheres are manufactured from polyether ether ketone (PEEK), a high-performance polymer known for its strength, biocompatibility, and resistance to wear. This material supports long-term structural integrity in spinal fusion procedures.

  • Who is the manufacturer and where can I contact them for inquiries?

    The manufacturer of the PEEK Spinal Spheres is Interbody Innovations, LLP, located at 1001 Oakwood Blvd., Round Rock, TX 78681. For inquiries, you may contact J.D. Webb, though direct contact details would need to be verified through official channels.