BEUDAMED
    FDA Registration Active 🇺🇸 United States

    GLOBUS MEDICAL, INC.

    Reg #: 3004142400 · FEI: 3004142400 · Expires 2026
    View on FDA
    Products
    86
    Proprietary Names
    176
    Establishment Types
    2
    Classifications
    86

    Registration Details

    Registration Name
    GLOBUS MEDICAL, INC.
    Registration Number
    3004142400
    FEI Number
    3004142400
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    2560 General Armistead Ave, VALLEY FORGE BUSINESS CENTER
    City
    AUDUBON
    State
    PA
    ZIP
    19403
    Country
    US

    Regulatory Submissions

    510(k) Number
    K103340
    PMA Number
    P100003

    Owner / Operator

    Firm Name
    GLOBUS MEDICAL, INC.
    Operator Number
    9056090
    Address
    2560 GENERAL ARMISTEAD AVE., VALLEY FORGE BUSINESS CENTER
    City
    Audubon
    State
    PA
    Postal Code
    19403
    Country
    US
    Correspondent
    DANIEL S PAUL

    Products

    Device Name Product Code
    Orthosis, Spondylolisthesis Spinal Fixation MNH
    Syringe, Piston FMF
    Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use JQC
    Filler, Bone Void, Calcium Compound MQV
    Thoracolumbosacral Pedicle Screw System NKB
    Appliance, Fixation, Spinal Intervertebral Body KWQ
    Orthosis, Spinal Pedicle Fixation MNI
    Appliance, Fixation, Spinal Interlaminal KWP
    Orthopedic Stereotaxic Instrument OLO
    Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented LWJ
    Mixer, Cement, For Clinical Use JDZ
    Plate, Fixation, Bone HRS
    Washer, Bolt Nut HTN
    Screw, Fixation, Bone HWC
    Hip, Semi-Constrained, Cemented, Metal/Polymer + Additive, Cemented OQH
    Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented LZO
    Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented JDI
    Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous Cemented, Osteophilic Finish MAY
    Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented LPH
    Hip, Semi-Constrained, Cemented, Metal/Ceramic/Polymer + Additive, Porous Uncemented OQI
    Hip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, Uncemented OQG
    Orthosis, Spine, Plate, Laminoplasty, Metal NQW
    Spinal Vertebral Body Replacement Device MQP
    Impactor HWA
    Cement, Bone, Vertebroplasty NDN
    Intervertebral Fusion Device With Integrated Fixation, Cervical OVE
    Intervertebral Fusion Device With Bone Graft, Lumbar MAX
    Intervertebral Fusion Device With Integrated Fixation, Lumbar OVD
    Orthopedic Augmented Reality SBF
    Gauge, Depth HTJ
    Prosthesis, Hip, Hemi-, Femoral, Metal KWL
    Platelet And Plasma Separator For Bone Graft Handling ORG
    Intervertebral Fusion Device With Bone Graft, Cervical ODP
    Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer HSX
    Bur, Surgical, General & Plastic Surgery GFF
    Arthroscope HRX
    Sacroiliac Joint Fixation OUR
    Neurological Stereotaxic Instrument HAW
    Bit, Drill HTW
    Prosthesis, Spinous Process Spacer/Plate NQO
    Bone Fixation Cerclage, Sublaminar OWI
    Nail, Fixation, Bone JDS
    Rod, Fixation, Intramedullary And Accessories HSB
    Prosthesis, Intervertebral Disc MJO
    Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer JWH
    Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, Metal Composite LXT
    Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component KTT
    Driver, Prosthesis HWR
    Retractor GAD
    Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Porous MBL
    Spinous Process Plate PEK
    Posterior Cervical Screw System NKG
    Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive OIY
    System, Facet Screw Spinal Device MRW
    Prosthesis, Hip, Femoral Component, Cemented, Metal JDG
    Apparatus, Autotransfusion CAC
    Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis OSH
    Spinal Vertebral Body Replacement Device - Cervical PLR
    Growing Rod System PGM
    Joint, Knee, External Brace ITQ
    Separator, Automated, Blood Cell, Diagnostic GKT
    Extractor HWB
    Reamer HTO
    Prosthesis, Elbow, Hemi-, Radial, Polymer KWI
    Motor, Surgical Instrument, Ac-Powered GEY
    Intervertebral Fusion Device With Bone Graft, Thoracic PHM
    Posterior Metal/Polymer Spinal System, Fusion NQP
    Bone Mill LYS
    Screwdriver HXX
    Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment HWE
    Cerclage, Fixation JDQ
    Broach HTQ
    Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer MBH
    Lipoaspirate Washing System For Aesthetic Body Contouring QKL
    Table, Surgical With Orthopedic Accessories, Manual JEB
    Wrench HXC
    Vertebral Body Tethering System QHP
    Fastener, Fixation, Nondegradable, Soft Tissue MBI
    Laparoscope, General & Plastic Surgery GCJ
    Device, Fixation, Proximal Femoral, Implant JDO
    Caliper KTZ
    Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented KWY
    Bone Grafting Material, Synthetic LYC
    Template HWT
    Bone Cement, Posterior Screw Augmentation PML
    Orthopedic Manual Surgical Instrument LXH

    Proprietary Names

    SmartPrep Harvest SmartPrep2 BMAC MicroFuse with Barium Sulfate REVERE ExcelsiusFlex DUAL TAPER WEDGE ANTHEM PROVIDENT CANOPY Laminoplasty Fixation System SUSTAIN RADIOLUCENT SPACER XTEND FORTIFY Corpectomy Spacer ORTHOPEDIC MANUAL SURGICAL INSTRUMENT FORTRESS HEDRON REVLOK Fenestrated ELSA RETAIN RADIOLUCENT SPACER XPAND CORPECTOMY SPACER XPAND RADIOLUCENT CORPECTOMY ExcelsiusXR Depth Gauge For Clinical Use PROVIDENCE ANTERIOR CERVICAL PLATE GATEWAY THORACOLUMBAR PLATE SYSTEM CITADEL ANTERIO REVERE STABILIZATION SYSTEM Harvest PRP CAPTIVATE PATRIOT SPACERS: COLONIAL ACDF SPAC Patriot Signature Additional PROVEN Gen-Flex REVOLVE Additional Implants ASSURE AFFIRM VCF SI-LOK CREO BEACON STABILIZATION SYSTEM BIT, DRILL VIP ANTERIOR CERVICAL PLATE SYSTEM CONFIRM HILINE H-LINK Integrated Rod UNIFY ExcelsiusGPS PROTEX CT CERVICOTHORACIC SPINAL SY TEM PROTEX CT CERVICOTHORACIC SPINAL SYSTEM AUTOBAHN SECURE®-C Cervical Artificial Disc GENflex2 COALITION AGX SUSTAIN-IR ARBOR UNIFY¿ Dynamic Anterior Cervical Plate System CROSSWAY Modulus SHIELD VCF FORTIFY¿ I and FORTIFY¿ I-R Corpectomy Spacers PATRIOT TPS Spacers FORTIFY I-R TPS Corpectomy Spacer FORTIFY-R TPS Corpectomy Spacer INDEPENDENCE TPS Spacers COALITION TPS Spacers XPand-R TPS Corpectomy Spacer NIKO TPS Corpectomy Spacer CALIBER TPS Spacers SUSTAIN R TPS Spacers Retractor Navigation Instruments ONVOY PROTRACT VERZA SP-Fix ACTIFY Uni PROTEX CT ELLIPSE FORTRESS-Plus TransContinental M ELLIPSE Additional Implants PLYMOUTH¿ Thoracolumbar Plate System CORRIDOR FIXATION SYSTEM INDEPENDENCE MIS PROGENY SUSTAIN MONUMENT INDEPENDENCE DuraPro SIGNIFY ExcelsiusGPS™ Instruments Harvest SmartCell REVERE 4.5 Stabilization System Proven Gen-Flex FORTIFY InstaFill QUARTEX CORBEL SCRIPT ZYFUSE TRUSS THORACOLUMBAR PLATE SYSTEM PATRIOT TransContinenetal Lateral PATRIOT Spacers REVERE Sacral Plates ELLIPSE OCCIPITO-CERVICO-THORACIC S NIKO Corpectomy Spacer HAVEN JOINT, KNEE, EXTERNAL BRACE VICTORY CoCr Rods REVOLVE STABILIZATION SYSTEM MicroFuse Bone Void Filler PROTEX STABILIZATION SYSTEM PROCLASS REVERE 6.35 STABILIZATION SYSTEM SILC COALITION® Spacer MICROFUSE BONE VOID FILLER POSTEREO SABLE BIOLOX DELTA AERIAL Harvest SmartPrep2 REVEL LATIS Spacers ASSURE ANTERIOR CERVICAL PLATE SYST STRETTO MicroFuse Putty & MIS Harvest CREO Stabilization System CITADEL ANTERIOR LUMBAR PLATE SYSTEM Bone Cement TRANSCONTINENTAL INTERCONTINENTAL COALITION KINEX CORRIDOR ACTIFY 3D Harvest Adiprep PROFORM RELIEVE LAMINOPLASTY FIXATION SYSTE BEACON Stabilization System Harvest SmartPrep COALITION SPACER RISE¿ Spacer MAGNIFY Spacers MARVEL INDEPENDENCE SPACER RIB LINK REVERE CROSSTOP CALIBER RESONATE TABLE, SURGICAL WITH ORTHOPEDIC ACCESSORIES, MANUAL ALTERA TRANSITION STABILIZATION SYSTEM REFLECT Capitol - Ellipse Additional COLONIAL COLOSSEUM PATRIOT REVERE Additional Implants TENSOR ALVUE SUSTAIN® and SUSTAIN® Radiolucent (SUSTAIN® R) Spacers BEACON ML CONNECTORS EXCELSIUS GPS REVERE UNIPLANAR SCREWS ADIRA InterContinental Plate-Spacer Calipers For Clinical Use Harvest Graft Delivery Caliber Additional Implants COSINE PROVIDENT II Harvest SmartJet Template For Clinical Use COALITION MIS REVLOK Globus Medical Manual Surgical Instruments

    Establishment Types

    Manufacture Device in the United States for Export Only Manufacture Medical Device