Skip to content

Kalitec Navigated Instrument System

by Kalitec Direct, LLC Doing Business AS Kalitec Medical

510(k) K232572

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 NumberK232572 Date13 Dec 2023ClearedStatusActive

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  • Withdrawn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
OLO
Device Class
Class II
Regulation
21 CFR Part 882.4560
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 Kalitec Navigated Instrument System is a stereotaxic instrument (Product Code: OLO) under 21 CFR 882.4560, designed for precise navigation and guidance in surgical procedures. It integrates imaging and real-time tracking to assist in accurate placement of instruments or implants, particularly in neurosurgical and spinal applications. The system enhances procedural precision by aligning with preoperative planning and intraoperative imaging data. Its classification as a Class II device reflects its role in reducing risks associated with manual placement techniques.

This system is supplied as a reusable medical device, intended for use in sterile operating environments. It requires compatibility with MRI-compatible navigation systems and may include components such as probes, guides, or tracking markers. The device is regulated under FDA 510(k) clearance (K232572) with a traditional review pathway, ensuring compliance with U.S. regulatory standards. Storage and handling follow standard sterile instrument protocols to maintain functionality and safety for repeated use in clinical settings.

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 Kalitec Navigated Instrument System used for?

    The Kalitec Navigated Instrument System is designed for precise navigation and guidance during surgical procedures, particularly in neurosurgical and spinal applications. It integrates imaging and real-time tracking to assist in accurate placement of instruments or implants, aligning with preoperative planning and intraoperative imaging data. This reduces risks associated with manual placement techniques by enhancing procedural precision.

  • Is the Kalitec Navigated Instrument System reusable or single-use?

    The Kalitec Navigated Instrument System is supplied as a reusable medical device. It is intended for use in sterile operating environments and requires adherence to standard sterile instrument protocols for storage and handling to ensure repeated safe clinical use.

  • What compatibility requirements does this system have?

    The system is designed to be compatible with MRI-compatible navigation systems. It may include components such as probes, guides, or tracking markers to facilitate accurate intraoperative alignment and real-time tracking during procedures.

  • How is the Kalitec Navigated Instrument System regulated?

    The device is regulated under the FDA 510(k) clearance pathway with the clearance number K232572. It follows a traditional review process and is classified as a Class II device under 21 CFR 882.4560, ensuring compliance with U.S. regulatory standards for medical devices.

  • What storage and handling protocols should be followed for this system?

    The Kalitec Navigated Instrument System must be stored and handled according to standard sterile instrument protocols to maintain its functionality and safety for reuse. Proper cleaning, sterilization, and storage in a sterile environment are critical to ensure the device remains effective and safe for repeated clinical use.