Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Navigation Instruments

K-Number: K153203 · 2016-02-03

ApplicantGlobus Medical, Inc.
Decision Date2016-02-03
Product CodeOLO
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

Navigation Instruments is a medical device manufactured by Globus Medical, Inc.. It received FDA 510(k) clearance on 2016-02-03 under approval number K153203. 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 Navigation Instruments?

Navigation Instruments is a medical device that received FDA 510(k) clearance on 2016-02-03. It is manufactured by Globus Medical, Inc.. The 510(k) number is K153203.

When was Navigation Instruments approved by the FDA?

Navigation Instruments received FDA 510(k) clearance on 2016-02-03, under approval number K153203.

What company makes Navigation Instruments?

Navigation Instruments is manufactured by Globus Medical, Inc..

What is the FDA product code for Navigation Instruments?

The FDA product code for Navigation Instruments is OLO.

Related Clinical Trials

NCT07518615 Clinical Safety and Effectiveness of the Straumann Dynamic Navigation System Falcon RECRUITING

Other Devices by Globus Medical, Inc.

K161379ELSA Spacers K161591QUARTEX™ Occipito-Cervico-Thoracic Spinal System, Globus Navigation Instruments K160597INDEPENDENCE MIS Spacers K161223TransContinental® M Spacers and InterContinental® Plate-Spacers K143578SUSTAIN R TPS Spacers, PATRIOT TPS Spacers, CALIBER TPS Spacer, COALITION TPS Spacers, INDEPENDENCE TPS Spacer, FORTIFY -R TPS Corpectomy Spacer, FORTIFY I-R TPS Corpectomy Spacer, XPand -R TPS Corpectomy Spacer, NIKO TPS Corpectomy Spacer K151665SUSTAIN Additional Implants

View all 91 devices →

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.

↑