GLOBUS MEDICAL, INC.

FDA Device Registration & Listing · Methuen, MA, US · Registration 3011713200

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3011713200
FEI Number
3011713200
Entity Name
GLOBUS MEDICAL, INC.
City/State/Country
Methuen, MA, US
Establishment Address
300 GRIFFIN BROOK DRIVE, Methuen, MA 01844, US
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
GLOBUS MEDICAL, INC. (Owner Number: 9056090)
Owner / Operator Contact Address
2560 GENERAL ARMISTEAD AVE., VALLEY FORGE BUSINESS CENTER, Audubon, PA 19403, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K191100
PMA Number
N/A

All Registered Proprietary Names

EXCELSIUS GPS SURGIMAP Excelsius3D EXCELSIUS GPS

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
OLO Orthopedic Stereotaxic Instrument Neurology Class 2 882.4560 2020-07-14
HAW Neurological Stereotaxic Instrument Neurology Class 2 882.4560 2020-07-14
LLZ System, Image Processing, Radiological Radiology Class 2 892.2050 2021-04-15
JAA System, X-Ray, Fluoroscopic, Image-Intensified Radiology Class 2 892.1650 2021-08-31
OXO Image-Intensified Fluoroscopic X-Ray System, Mobile Radiology Class 2 892.1650 2021-08-31
OWB Interventional Fluoroscopic X-Ray System Radiology Class 2 892.1650 2021-08-31
OLO Orthopedic Stereotaxic Instrument Neurology Class 2 882.4560 2019-07-26

Official Correspondent

DANIEL PAUL

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

GLOBUS MEDICAL, INC.
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Other Registrations for Same Entity

Registration Number Establishment Name Location
3000779542 Tissue Transplant Technology, Ltd. d/b/a Bone Bank Allografts San Antonio, TX, US
3030412764 GLOBUS MEDICAL, INC. Memphis, TN, US
3004142400 GLOBUS MEDICAL, INC. AUDUBON, PA, US
3013491327 NML Medical, LLC West Carrollton, OH, US

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K260601 Blue Belt Technologies, Inc. REAL INTELLIGENCE™ CORI™ 2026-03-26
K010427 Walter Lorenz Surgical, Inc. LORENZ FIDUCAIL SCREW 2001-03-15
K812744 Progress Mankind Technology LEVY BIOTAC #LX001 BIOPSY PROBE HOLDER 1981-12-03
K092467 Brainlab AG VECTORVISION CRANIAL, VECTORVISION ENT, KOLIBRI CRANIAL, KOLIBRI ENT, CRANIAL ESSENTIAL, CRANIAL UNLIMITED 2010-05-06
K031454 Biomet, Inc. ACUMEN SURGICAL NAVIGATION SYSTEM 2004-07-08

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0041-2024 Blue Belt Technologies, Inc 2
Real Intelligence CORI RI.KNEE v2.0 TKA (Total Knee Arthroplasty) software version 2.0 (2.0.0.5) Product Number: ROB10299
Z-0001-2012 Medtronic Navigation, Inc 2
Probe, Tactile, Left, ASM, Long, Part #962009S, Medtronic Navigation, Louisville, CO 80027. Trackable hand held instruments used in spine surgeries for preparation of the pedicle. These instruments are used in conjunction with the Medtronic Navigation StealthStation platform and various software applications.
Z-0002-2012 Medtronic Navigation, Inc 2
Probe, Tactile, Right, ASM, Long, Part #962011S, Medtronic Navigation, Louisville, CO 80027. Trackable hand held instruments used in spine surgeries for preparation of the pedicle. These instruments are used in conjunction with the Medtronic Navigation StealthStation platform and various software applications.
Z-0005-2007 Stryker Instruments Div. of Stryker Corporation 2
Stryker Navigation System, eNlite System with Dell laptop computer model D800, Stryker # 7700-300-000.
Z-0006-2007 Stryker Instruments Div. of Stryker Corporation 2
Stryker Navigation System Remote Planning Stations with Dell laptop computer model D800, Stryker # 7700-010-000 and 6000-300-000.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3011713200. Last updated year: 2026. Please use registration number 3011713200 when referencing this establishment in official correspondence.
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