FDA Registration
Active
🇺🇸 United States
GLOBUS MEDICAL, INC.
Reg #: 3030412764
·
FEI: 3030412764
·
Expires 2026
Products
77
Proprietary Names
137
Establishment Types
1
Classifications
77
Registration Details
- Registration Name
- GLOBUS MEDICAL, INC.
- Registration Number
- 3030412764
- FEI Number
- 3030412764
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 4670 E. SHELBY DR
- City
- Memphis
- State
- TN
- ZIP
- 38118
- Country
- US
Regulatory Submissions
- 510(k) Number
- K062590
- 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 | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Appliance, Fixation, Spinal Intervertebral Body | KWQ | Class 2 | Orthopedic | No | 2024-01-24 |
| Appliance, Fixation, Spinal Interlaminal | KWP | Class 2 | Orthopedic | No | 2024-01-29 |
| Thoracolumbosacral Pedicle Screw System | NKB | Class 2 | Orthopedic | No | 2024-01-29 |
| Orthosis, Spinal Pedicle Fixation | MNI | Class 2 | Orthopedic | No | 2024-01-29 |
| Orthosis, Spondylolisthesis Spinal Fixation | MNH | Class 2 | Orthopedic | No | 2024-01-29 |
| Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis | OSH | Class 2 | Orthopedic | No | 2024-01-29 |
| Intervertebral Fusion Device With Bone Graft, Cervical | ODP | Class 2 | Orthopedic | No | 2024-01-24 |
| Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer | JWH | Class 2 | Orthopedic | No | 2023-06-13 |
| Interventional Fluoroscopic X-Ray System | OWB | Class 2 | Radiology | No | 2024-01-31 |
| System, Image Processing, Radiological | LLZ | Class 2 | Radiology | No | 2024-01-31 |
| System, X-Ray, Fluoroscopic, Image-Intensified | JAA | Class 2 | Radiology | No | 2024-01-31 |
| Intervertebral Fusion Device With Integrated Fixation, Lumbar | OVD | Class 2 | Orthopedic | No | 2024-01-29 |
| Intervertebral Fusion Device With Bone Graft, Lumbar | MAX | Class 2 | Orthopedic | No | 2024-01-29 |
| Intervertebral Fusion Device With Bone Graft, Thoracic | PHM | Class 2 | Orthopedic | No | 2024-01-29 |
| Filler, Bone Void, Calcium Compound | MQV | Class 2 | Orthopedic | No | 2015-01-28 |
| Spinal Vertebral Body Replacement Device | MQP | Class 2 | Orthopedic | No | 2024-01-24 |
| Manual Instruments Designed For Use With Total Disc Replacement Devices | QLQ | Class 2 | Orthopedic | No | 2024-02-04 |
| Posterior Cervical Screw System | NKG | Class 2 | Orthopedic | No | 2024-02-01 |
| System, Facet Screw Spinal Device | MRW | Class U | Unknown | No | 2024-02-01 |
| Prosthesis, Hip, Hemi-, Femoral, Metal | KWL | Class 2 | Orthopedic | No | 2023-06-13 |
| Cement, Bone, Vertebroplasty | NDN | Class 2 | Orthopedic | No | 2017-01-26 |
| Screw, Fixation, Bone | HWC | Class 2 | Orthopedic | No | 2017-07-24 |
| Plate, Fixation, Bone | HRS | Class 2 | Orthopedic | No | 2017-07-24 |
| Orthopedic Stereotaxic Instrument | OLO | Class 2 | Neurology | No | 2024-05-16 |
| Stimulator, Nerve | ETN | Class 2 | Ear, Nose, Throat | No | 2024-02-04 |
| Stretcher, Wheeled, Powered | INK | Class 2 | Physical Medicine | No | 2024-02-04 |
| Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous Cemented, Osteophilic Finish | MAY | Class 2 | Orthopedic | No | 2022-12-19 |
| Hip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, Uncemented | OQG | Class 2 | Orthopedic | No | 2022-12-19 |
| Hip, Semi-Constrained, Cemented, Metal/Ceramic/Polymer + Additive, Porous Uncemented | OQI | Class 2 | Orthopedic | No | 2022-12-19 |
| Hip, Semi-Constrained, Cemented, Metal/Polymer + Additive, Cemented | OQH | Class 2 | Orthopedic | No | 2022-12-19 |
| Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented | LPH | Class 2 | Orthopedic | No | 2022-12-19 |
| Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented | LWJ | Class 2 | Orthopedic | No | 2022-12-19 |
| Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented | LZO | Class 2 | Orthopedic | No | 2022-12-19 |
| Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented | JDI | Class 2 | Orthopedic | No | 2022-12-19 |
| Rod, Fixation, Intramedullary And Accessories | HSB | Class 2 | Orthopedic | No | 2022-09-12 |
| Nail, Fixation, Bone | JDS | Class 2 | Orthopedic | No | 2022-09-12 |
| Prosthesis, Intervertebral Disc | MJO | Class 3 | Unknown | No | 2012-11-26 |
| Stimulator, Nerve, Ac-Powered | BXM | Class 2 | Anesthesiology | No | 2024-02-04 |
| Spinous Process Plate | PEK | Class 2 | Orthopedic | No | 2024-01-23 |
| Light, Surgical, Fiberoptic | FST | Class 2 | General, Plastic Surgery | No | 2024-02-01 |
| Prosthesis, Hip, Femoral Component, Cemented, Metal | JDG | Class 2 | Orthopedic | No | 2023-06-13 |
| Electromyograph, Diagnostic | IKN | Class 2 | Physical Medicine | No | 2024-02-01 |
| Mixer, Cement, For Clinical Use | JDZ | Class 1 | Orthopedic | No | 2023-06-13 |
| Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer | HSX | Class 2 | Orthopedic | No | 2023-06-13 |
| Sacroiliac Joint Fixation | OUR | Class 2 | Orthopedic | No | 2012-01-20 |
| Formalin, Neutral Buffered | IFP | Class 1 | Pathology | No | 1995-06-21 |
| Intervertebral Fusion Device With Integrated Fixation, Cervical | OVE | Class 2 | Orthopedic | No | 2024-01-26 |
| Bone Fixation Cerclage, Sublaminar | OWI | Class 2 | Orthopedic | No | 2024-02-01 |
| Vertebral Body Tethering System | QHP | Class N | Unknown | No | 2023-05-16 |
| Stimulator, Electrical, Evoked Response | GWF | Class 2 | Neurology | No | 2024-02-01 |
| Fastener, Fixation, Nondegradable, Soft Tissue | MBI | Class 2 | Orthopedic | No | 2024-06-13 |
| Washer, Bolt Nut | HTN | Class 2 | Orthopedic | No | 2024-06-13 |
| Neurological Stereotaxic Instrument | HAW | Class 2 | Neurology | No | 2024-02-01 |
| Neurosurgical Nerve Locator | PDQ | Class 2 | Ear, Nose, Throat | No | 2024-02-01 |
| Syringe, Piston | FMF | Class 2 | General Hospital | No | 2022-08-22 |
| Impactor | HWA | Class 1 | Orthopedic | No | 2024-08-23 |
| Cerclage, Fixation | JDQ | Class 2 | Orthopedic | No | 2023-08-09 |
| Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment | HWE | Class 1 | General, Plastic Surgery | No | 2024-04-01 |
| Electrosurgical, Cutting & Coagulation & Accessories | GEI | Class 2 | General, Plastic Surgery | No | 2024-01-31 |
| Bone Cement, Posterior Screw Augmentation | PML | Class 2 | Orthopedic | No | 2024-02-02 |
| Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive | OIY | Class 2 | Orthopedic | No | 2024-07-11 |
| Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer | MBH | Class 2 | Orthopedic | No | 2024-07-11 |
| Orthosis, Spine, Plate, Laminoplasty, Metal | NQW | Class 2 | Orthopedic | No | 2024-02-02 |
| Spinal Vertebral Body Replacement Device - Cervical | PLR | Class 2 | Orthopedic | No | 2024-01-24 |
| Motor, Surgical Instrument, Ac-Powered | GEY | Class 1 | General, Plastic Surgery | No | 2024-04-01 |
| Mesh, Surgical, Polymeric | FTL | Class 2 | General, Plastic Surgery | No | 2024-02-01 |
| Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented | KWY | Class 2 | Orthopedic | No | 2023-06-13 |
| Growing Rod System | PGM | Class 2 | Orthopedic | No | 2024-02-02 |
| Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Porous | MBL | Class 2 | Orthopedic | No | 2025-06-18 |
| Bit, Drill | HTW | Class 1 | Orthopedic | No | 2015-05-28 |
| Posterior Metal/Polymer Spinal System, Fusion | NQP | Class 2 | Orthopedic | No | 2009-12-18 |
| Device, Fixation, Proximal Femoral, Implant | JDO | Class 2 | Orthopedic | No | 2023-06-13 |
| Retractor | GAD | Class 1 | General, Plastic Surgery | No | 2015-05-28 |
| Cuff, Tracheal Tube, Inflatable | BSK | Class 2 | Anesthesiology | No | 2024-02-01 |
| Tube, Tracheal (W/Wo Connector) | BTR | Class 2 | Anesthesiology | No | 2024-02-01 |
| Orthopedic Manual Surgical Instrument | LXH | Class 1 | Orthopedic | No | 2012-09-24 |
| Bur, Surgical, General & Plastic Surgery | GFF | Class 1 | General, Plastic Surgery | No | 2024-04-01 |
Proprietary Names
HeliX
RELINE
CoRoent
Archon
GENflex2
PROVEN Gen-Flex
LessRay
Cohere
Brigade
Modulus
Coalesce
BASE
Caliber Additional Implants
INDEPENDENCE MIS
KINEX
Simplify
XLP Lateral Plate
SpheRx
Triad Facet
PROVIDENT
FORTRESS-Plus
ANTHEM
DuraPro
NVJJB
BIOLOX DELTA
AUTOBAHN
ZYFUSE
Navigation Instruments
X-Core
StruXure
XLIF Decade Plate
Stimulation/Dissection Instruments
Armada
Bendini
Foundation
SECURE®-C Cervical Artificial Disc
AffiX
MaXcess
PROGENY
InterContinental Plate-Spacer
MESH Implants
DUAL TAPER WEDGE
MLX
TLX
Traverse
SI-LOK
Formalde-Fresh Solution, Buffered, Fisher Chemical
Prefilled Containers, 10% NBF
Prefilled Dermatology Containers, 10% NBF
Neutral Buffered Formalin 10%
20% Buffered Formalin
Concentrated Neutral Buffered Formalin
Formalin, Buffered, 10% (Phosphate Buffer/Certified)
Blue Formalin
R21923 Formalin 10%
Formalin, Buffered, 10% (Acetate Buffer/Certified)
HandiPack Containers, 10% NBF
R21640 Formalin 10%,
Syntri Safeguard, 10% NBF
Prostate Kits
ALIF Buttress Plate
ACP
NuVaLine
Monolith
VersaTie
FORTRESS
SIGNIFY
PRECEPT
VuePoint
REFLECT
NVM5
TENSOR
PROCLASS
RIB LINK
RETAIN RADIOLUCENT SPACER
XPAND CORPECTOMY SPACER
XPAND RADIOLUCENT CORPECTOMY
MAS PLIF
RISE¿ Spacer
PEEK Corpectomy
SILC
PROTRACT
InstaFill
ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
STRETTO
SUSTAIN RADIOLUCENT SPACER
FormaGraft
HEDRON
Helix
Gradient
Halo
Forceps
PULSE
Affix
TraVerse
APX
ACTIFY 3D
Modulus Expandable
Camber
ACTIFY Uni
PCM
Rod Registration Frame
REVLOK Fenestrated
PROVIDENT II
Growth Rod
ONVOY
XLX
FORTIFY
BIT, DRILL
Radian
ET Tube
GSB Global Spinal Balance
VERZA
Embrace
INDEPENDENCE SPACER
AttraX
TRANSITION STABILIZATION SYSTEM
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
PROFORM
CORBEL
LeVerage
QUARTEX
Retractor
XLIF Stimulating Electrode
Proven Gen-Flex
Precept
CREO
SABLE
Globus Medical Manual Surgical Instruments
Establishment Types
Manufacture Medical Device