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K2M Navigation Instruments

by K2M, Inc.

510(k) K201006

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 · Special NumberK201006 Date7 Aug 2020ClearedStatusActive

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  • Withdrawn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, 25 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 K2M Navigation Instruments are manual surgical tools designed to interface with navigation systems such as the Medtronic StealthStation System or Brainlab Navigation System. They are used during spinal procedures to assist in the preparation and placement of K2M pedicle screws, facilitating precise location of anatomical structures in open or minimally invasive surgeries.

The instruments include nonsterile, reusable surgical tools such as inserters, taps, probes, and awls, as well as single-use drill bits. They are intended for use in cervical and thoracolumbar spinal surgery and are classified under the OLO product code for orthopedic stereotaxic instruments. The device is not sterile and is reusable, with storage requirements not specified in the provided data.

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Questions

AI-generated answers, 25 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 are the K2M Navigation Instruments used for?

    These instruments are manual surgical tools used during spinal procedures to assist in the preparation and placement of K2M pedicle screws. They interface with navigation systems like the Medtronic StealthStation or Brainlab Navigation System to help locate anatomical structures during open or minimally invasive surgeries.

  • Are the K2M Navigation Instruments sterile?

    No, the K2M Navigation Instruments are not sterile. The device includes both nonsterile, reusable surgical tools such as inserters, taps, probes, and awls, as well as single-use drill bits.

  • What types of surgical tools are included in the K2M Navigation Instruments set?

    The set includes a variety of manual surgical tools, such as inserters, taps, probes, and awls. These are reusable and nonsterile. Additionally, the set includes single-use drill bits.

  • What is the intended use for the K2M Navigation Instruments?

    The instruments are intended for use in cervical and thoracolumbar spinal surgery. They are designed to assist surgeons in the precise location of anatomical structures during the preparation and placement of K2M pedicle screws.