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E-GPS Navigated Instruments

by Precision Spine, Inc.

510(k) K220862

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 NumberK220862 Date14 Jul 2022ClearedStatusActive

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  • Withdrawn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, 21 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 E-GPS Navigated Instruments are orthopedic stereotaxic instruments indicated for use during the preparation and placement of Precision Spine screws during spinal surgery. They assist the surgeon in precisely locating anatomical structures in either open or minimally invasive procedures.

The device has been evaluated through an engineering analysis and geometric comparison to predicate devices to establish safety and efficacy for accuracy performance. It is supplied as part of a navigated instrument system and has received FDA 510(k) clearance with the K number K220862, classified under product code OLO as Class II - Special Controls.

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Questions

AI-generated answers, 21 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 E-GPS Navigated Instruments used for?

    E-GPS Navigated Instruments are orthopedic stereotaxic instruments indicated for use during the preparation and placement of Precision Spine screws during spinal surgery, assisting surgeons in precisely locating anatomical structures in either open or minimally invasive procedures.

  • How are E-GPS Navigated Instruments supplied?

    The device is supplied as part of a navigated instrument system and has received FDA 510(k) clearance with the K number K220862, classified under product code OLO as Class II - Special Controls.

  • What is the regulatory status of E-GPS Navigated Instruments?

    The device has been evaluated through an engineering analysis and geometric comparison to predicate devices to establish safety and efficacy for accuracy performance. It has received FDA 510(k) clearance with the K number K220862.

  • Can E-GPS Navigated Instruments be used in both open and minimally invasive procedures?

    Yes, E-GPS Navigated Instruments are designed to assist surgeons in precisely locating anatomical structures during spinal surgery in both open and minimally invasive procedures.