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FDA 510(k)

GX Navigation Instrument System

K-Number: K202836 · 2021-08-19

ApplicantLife Spine, Inc.
Decision Date2021-08-19
Product CodeOLO
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

GX Navigation Instrument System is a medical device manufactured by Life Spine, Inc.. It received FDA 510(k) clearance on 2021-08-19 under approval number K202836. The device is classified under product code OLO. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GX Navigation Instrument System?

GX Navigation Instrument System is a medical device that received FDA 510(k) clearance on 2021-08-19. It is manufactured by Life Spine, Inc.. The 510(k) number is K202836.

When was GX Navigation Instrument System approved by the FDA?

GX Navigation Instrument System received FDA 510(k) clearance on 2021-08-19, under approval number K202836.

What company makes GX Navigation Instrument System?

GX Navigation Instrument System is manufactured by Life Spine, Inc..

What is the FDA product code for GX Navigation Instrument System?

The FDA product code for GX Navigation Instrument System is OLO.

Related Clinical Trials

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Related PubMed Literature

PMID: 40775988 B-onic Suite: An Integrated Platform for Personalized Medical Devices, Real-Time Surgical Planning, and Enhanced Intraoperative Navigation. Studies in health technology and informatics (2025)

Other Devices by Life Spine, Inc.

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Related Devices (Code: OLO)

K162375Envision 3D: Image Guidance System7D Surgical, Inc. K162341Stryker OrthoMap Precision Knee systemStryker Leibinger GmbH & Co KG K162195TSolution One Cup1 Surgical SystemTHINK Surgical, Inc. K160385Precision ScrewCryptych Pty, Ltd. K153700Aesculap(R) Implant Systems (AIS) S4 Navigation InstrumentsAesculap Implant Systems, LLC K153240Styrker OrthoMap Express Knee SystemStryker Corporate

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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