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Brainlab Compatible K2M Navigation Instruments

by K2m

510(k) K181890

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 NumberK181890 Date9 Nov 2018ClearedStatusActive

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  • Withdrawn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, 19 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

Brainlab Compatible K2M Navigation Instruments are hand-held surgical instruments intended to be used during implantation of an orthopaedic prosthesis, either manually or as a computer-assisted system. They are designed for use with the Brainlab Navigation system to assist the surgeon in precisely locating anatomical structures during spinal surgery.

These instruments are used in the preparation and placement of K2M pedicle screws (DENALI, MESA, EVEREST, YUKON) during open or minimally invasive spinal procedures. They are supplied as non-sterile, reusable devices and are classified as Orthopedic Stereotaxic Instruments under FDA product code OLO, with FDA 510(k) clearance K181890.

Other devices from K2M, Inc.

See all devices from K2M, Inc. →

Questions

AI-generated answers, 19 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 Brainlab Compatible K2M Navigation Instruments used for?

    These instruments are hand-held surgical tools used during implantation of orthopedic prostheses, specifically for preparing and placing K2M pedicle screws in open or minimally invasive spinal procedures.

  • How are Brainlab Compatible K2M Navigation Instruments supplied?

    The instruments are supplied as non-sterile, reusable devices that are designed to be used with the Brainlab Navigation system to assist surgeons in precisely locating anatomical structures during spinal surgery.

  • What types of screws can be used with these instruments?

    These instruments are specifically designed for use with K2M pedicle screws including the DENALI, MESA, EVEREST, and YUKON models during spinal procedures.

  • What is the regulatory classification of these instruments?

    They are classified as Orthopedic Stereotaxic Instruments under FDA product code OLO, with FDA 510(k) clearance K181890.