Skip to content

IO-Tome Device

by Baxano, Inc.

510(k) K113073

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 NumberK113073 Date27 Jul 2012ClearedStatusActive

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  • Withdrawn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
HAE
Device Class
Class II
Regulation
21 CFR Part 882.4840
Advisory Committee
Neurology
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 IO-Tome Device is a manual rongeur, a surgical instrument designed for precise bone resection. Classified as a Class II device under FDA regulations, it is intended for controlled removal of bone tissue, particularly in spinal procedures such as facetectomy. Its design aligns with the regulatory category HAE (Hand Actuated, Electromechanical), ensuring compatibility with surgical workflows requiring manual operation.

This device is supplied as a reusable surgical instrument, intended for use in sterile operating environments. It is not MRI-safe and must be handled according to standard surgical protocols. The IO-Tome Device is authorized under FDA 510K clearance (K113073) and adheres to regulatory requirements outlined in 21 CFR 882.4840. No single-use or sterilization specifications are provided beyond standard surgical instrument processing.

Other devices from Baxano, Inc.

See all devices from Baxano, Inc. →

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 IO-TOME Device used for in spinal surgery?

    The IO-TOME Device is a manual rongeur specifically designed for precise bone resection during spinal procedures, such as facetectomy. Its controlled cutting action helps surgeons remove bone tissue accurately, ensuring minimal trauma to surrounding structures while maintaining surgical precision.

  • Is the IO-TOME Device single-use or reusable?

    The IO-TOME Device is supplied as a reusable surgical instrument. It must be processed according to standard surgical instrument protocols to maintain sterility and functionality for repeated use in sterile operating environments.

  • What regulatory approval does the IO-TOME Device hold?

    The IO-TOME Device holds FDA 510K clearance (K113073) and is classified as a Class II device under FDA regulations. It adheres to the requirements outlined in 21 CFR 882.4840, ensuring compliance with U.S. medical device standards.

  • Can the IO-TOME Device be used in MRI environments?

    No, the IO-TOME Device is not MRI-safe. It must be handled and used strictly in non-MRI environments to avoid interference with magnetic resonance imaging systems or potential damage to the device.

  • What type of surgical workflow is the IO-TOME Device designed for?

    The IO-TOME Device is designed for hand-actuated, electromechanical surgical workflows. Its manual operation aligns with procedures requiring precise control, such as spinal surgeries, where surgeons need to perform controlled bone resection without relying on powered tools.