Medical Device Manufacturer · US , Audubon , PA

Globus Medical, Inc.

169 submissions · 166 cleared · Since 2003
169
Total
166
Cleared
0
Denied

Globus Medical, Inc. — FDA 510(k) Submissions

Globus Medical, Inc. has submitted 169 FDA 510(k) premarket notifications since 2003, of which 166 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Thoracolumbosacral Pedicle Screw System, Intervertebral Fusion Device With Bone Graft, Lumbar, Appliance, Fixation, Spinal Intervertebral Body, Orthopedic Stereotaxic Instrument, Spinal Vertebral Body Replacement Device . Use the specialty filter in the sidebar to narrow results.

169 devices
1–25 of 169
RIB LINK? Fixation System
K252166 · HRS Plate, Fixation, Bone · Orthopedic
Feb 2026 231d
HEDRON? Cervical Spacers (HEDRON C-MIS? Spacer)
K253876 · OVE Intervertebral Fusion... · Orthopedic
Dec 2025 18d
ExcelsiusGPS? Instruments
K250599 · OLO Orthopedic Stereotaxic... · Orthopedic
Nov 2025 250d
ANTHEM? Fracture System
K251161 · HRS Plate, Fixation, Bone · Orthopedic
Aug 2025 125d
ExcelsiusXR?
K241525 · SBF Orthopedic Augmented Reality · Orthopedic
Jul 2025 404d
ONVOY? Acetabular System
K243456 · LPH Prosthesis, Hip,... · Orthopedic
Jun 2025 211d
NuVasive Pulse System
K243814 · OLO Orthopedic Stereotaxic... · Orthopedic
Jan 2025 30d
ExcelsiusGPS? Instruments
K243671 · OLO Orthopedic Stereotaxic... · Orthopedic
Dec 2024 23d
ACTIFY? Unicondylar Knee System
K241260 · HSX Prosthesis, Knee,... · Orthopedic
Dec 2024 214d
COSINE? Spacer
K234035 · MAX Intervertebral Fusion... · Orthopedic
Sep 2024 261d
ACTIFY? 3D Total Knee System, ACTIFY? Total Knee System
K240669 · JWH Prosthesis, Knee,... · Orthopedic
Jun 2024 101d
ExcelsiusFlex?
K240721 · OLO Orthopedic Stereotaxic... · Orthopedic
Jun 2024 88d
TENSOR? Suture Button System
K240947 · HTN Washer, Bolt Nut · Orthopedic
Jun 2024 56d
DuraPro? Oscillating System
K240568 · OLO Orthopedic Stereotaxic... · Orthopedic
Apr 2024 60d
QUARTEX? Occipito-Cervico-Thoracic Spinal System ExcelsiusGPS? Instruments
K231850 · NKG Posterior Cervical Screw... · Orthopedic
Mar 2024 265d
VERZA? High Speed Drills
K233638 · OLO Orthopedic Stereotaxic... · Orthopedic
Feb 2024 88d
ADIRA? Lateral Plate System
K233735 · KWQ Appliance, Fixation,... · Orthopedic
Jan 2024 64d
VICTORY? Lumbar Plate System
K232318 · KWQ Appliance, Fixation,... · Orthopedic
Oct 2023 89d
STRETTO? Cable System
K231333 · JDQ Cerclage, Fixation · Orthopedic
Aug 2023 88d
Lumbar Expandable lnterbody Spacers -Additional Indications/Implants
K221894 · MAX Intervertebral Fusion... · Orthopedic
Aug 2023 399d
HILINE? Fixation System
K230565 · OWI Bone Fixation Cerclage,... · Orthopedic
Apr 2023 50d
MARVEL? Growing Rods
K213196 · PGM Growing Rod System · Orthopedic
Dec 2022 446d
HEDRON Cervical Spacers, HEDRON Lumbar Spacers, SABLE Expandable Spacer, ExcelsiusGPS Instruments
K222270 · ODP Intervertebral Fusion... · Orthopedic
Oct 2022 84d
ONVOY Acetabular System
K213842 · LPH Prosthesis, Hip,... · Orthopedic
Oct 2022 298d
AUTOBAHN(R) EVO Femoral Nails
K220659 · HSB Rod, Fixation,... · Orthopedic
Sep 2022 186d

Looking for a specific device from Globus Medical, Inc.? Search by device name or K-number.

Search all Globus Medical, Inc. devices
Filters