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Endoskeleton TC

by Titan Spine, LLC

510(k) K100889

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 NumberK100889 Date29 Jul 2010ClearedStatusActive

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  • Withdrawn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
ODP
Device class
Class II
Regulation
21 CFR Part 888.3080
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 Endoskeleton TC is a cervical interbody fusion device classified as an interbody spinal fusion device with integrated fixation. It is designed to provide structural support and stability to the cervical spine by acting as a bridge between adjacent vertebrae. The device features a cage with integrated fixation points to facilitate immediate mechanical stability during the fusion process. Its construction includes anti-backout mechanisms to prevent screw loosening and ensure proper alignment.

The Endoskeleton TC is supplied non-sterile and requires cleaning and sterilization prior to use, as outlined in Titan Spine’s recommended protocols. It is intended for reusable applications in spinal surgery settings, adhering to standard orthopedic surgical practices. The device is MRI-unsafe and must be used in environments where MRI compatibility is not required. Authorized for use under FDA 510(k) clearance (K100889), it is categorized under the Orthopedic advisory committee and falls under product code ODP for regulatory tracking.

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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 Endoskeleton TC used for?

    The Endoskeleton TC is designed as a cervical interbody fusion device with integrated fixation. It provides structural support and stability to the cervical spine by acting as a bridge between adjacent vertebrae, ensuring immediate mechanical stability during spinal fusion surgery. The integrated fixation points and anti-backout mechanisms help maintain proper alignment and prevent screw loosening.

  • How is the Endoskeleton TC supplied and prepared for use?

    The Endoskeleton TC is supplied in a non-sterile state. Before use, it must be cleaned and sterilized following Titan Spine’s recommended protocols. This ensures it meets surgical standards for reuse in spinal surgery settings, adhering to standard orthopedic practices.

  • Is the Endoskeleton TC single-use or reusable?

    The Endoskeleton TC is intended for reusable applications in spinal surgery. Its design and construction allow it to be cleaned, sterilized, and reused multiple times, provided it adheres to proper surgical protocols and maintenance guidelines.

  • What safety considerations should be taken with the Endoskeleton TC?

    The Endoskeleton TC is MRI-unsafe, meaning it should only be used in environments where MRI compatibility is not required. Clinicians must ensure the surgical setting does not involve MRI procedures, as the device could interfere with imaging or pose risks during scans.

  • What regulatory clearance does the Endoskeleton TC hold?

    The Endoskeleton TC holds FDA 510(k) clearance under the designation K100889. It was classified as substantially equivalent and reviewed by the Orthopedic Advisory Committee, falling under product code ODP for regulatory tracking. This clearance confirms its compliance with U.S. regulatory standards for spinal fusion devices.