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Globus Medical, Inc.: FDA-registered device maker in Methuen, MA, United States, 6 510(k) clearances

Name: Globus Medical, Inc. FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Globus Medical, Inc. is registered with the FDA (registration 3011713200) in Methuen, MA, United States. It lists 6 device types. The FDA files 6 510(k) clearances under its listings, the newest dated August 25, 2021. Registered through 2026. FDA data exported November 3, 2026.

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FDA registration number: 3011713200
Address: 300 Griffin Brook Drive, Methuen, MA, United States, 01844
Owner or operator: GLOBUS MEDICAL, INC. (9056090)
Roles: Manufacturer
First device listed: August 19, 2017
Registered through: 2026
Brand names listed: EXCELSIUS GPS, Excelsius3D, ExcelsiusHub, SURGIMAP

Devices it lists

Device	Product code	Class	Role	Source
Image-Intensified Fluoroscopic X-Ray System, Mobile	OXO	2	Manufacturer	accessdata.fda.gov
Interventional Fluoroscopic X-Ray System	OWB	2	Manufacturer	accessdata.fda.gov
Neurological Stereotaxic Instrument	HAW	2	Manufacturer	accessdata.fda.gov
Orthopedic Stereotaxic Instrument	OLO	2	Manufacturer	accessdata.fda.gov
System, Image Processing, Radiological	LLZ	2	Manufacturer	accessdata.fda.gov
System, X-Ray, Fluoroscopic, Image-Intensified	JAA	2	Manufacturer	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
August 25, 2021	K211616	ExcelsiusHub	OLO	Substantially Equivalent	Globus Medical, Inc.	accessdata.fda.gov
August 12, 2021	K210912	Excelsius3D	OWB	Substantially Equivalent	Globus Medical, Inc.	accessdata.fda.gov
July 10, 2020	K200047	ExcelsiusGPS Cranial 1.0 Module	OLO	Substantially Equivalent	Globus Medical, Inc.	accessdata.fda.gov
July 24, 2019	K191100	ExcelsiusGPS Spine 1.1 Interbody Module	OLO	Substantially Equivalent	Globus Medical, Inc.	accessdata.fda.gov
August 16, 2017	K171651	EXCELSIUS GPS	OLO	Substantially Equivalent	Globus Medical, Inc.	accessdata.fda.gov
September 19, 2014	K141669	SURGIMAP	LLZ	Substantially Equivalent	Nemaris, Inc.	accessdata.fda.gov

Compare with other makers

Updated August 25, 2021. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.