← Every applicant
Globus Medical, Inc. FDA Approvals
0 new drug approvals and 40 device clearances on file. Matched by name to GMED.
Newest first
A new drug approval is an original application; a 510(k) is a device shown equivalent to one already sold.
| Product |
|---|
| TRIVANCE Hip Stem510(k)Aug 4, 2026Orthopedic |
| ACTIFY Total Knee System, ACTIFY 3D Total Knee System (ACTIFY MC Tibial Insert)510(k)Jul 31, 2026Orthopedic |
| SCRIPT Rods, CREO Stabilization System, REVERE® Stabilization System, REVERE® 4.5 Stabilization System, NuVasive Reline System510(k)May 7, 2026Orthopedic |
| SCRIPT Implant System510(k)Apr 29, 2026Orthopedic |
| AUTOBAHN Nailing System510(k)Apr 24, 2026Orthopedic |
| RIB LINK Fixation System510(k)Feb 26, 2026Orthopedic |
| HEDRON Cervical Spacers (HEDRON C-MIS Spacer)510(k)Dec 22, 2025Orthopedic |
| ExcelsiusGPS Instruments510(k)Nov 5, 2025Neurology |
| ANTHEM® Fracture System510(k)Aug 18, 2025Orthopedic |
| ExcelsiusXR510(k)Jul 8, 2025Neurology |
| ONVOY Acetabular System510(k)Jun 6, 2025Orthopedic |
| NuVasive Pulse System510(k)Jan 10, 2025Neurology |
| ExcelsiusGPS® Instruments510(k)Dec 20, 2024Neurology |
| ACTIFY Unicondylar Knee System510(k)Dec 6, 2024Orthopedic |
| COSINE Spacer510(k)Sep 6, 2024Orthopedic |
| ACTIFY 3D Total Knee System, ACTIFY Total Knee System510(k)Jun 20, 2024Orthopedic |
| ExcelsiusFlex510(k)Jun 14, 2024Neurology |
| TENSOR® Suture Button System510(k)Jun 3, 2024Orthopedic |
| DuraPro Oscillating System510(k)Apr 29, 2024Neurology |
| QUARTEX® Occipito-Cervico-Thoracic Spinal System ExcelsiusGPS® Instruments510(k)Mar 14, 2024Orthopedic |
| VERZA High Speed Drills510(k)Feb 9, 2024Neurology |
| ADIRA Lateral Plate System510(k)Jan 25, 2024Orthopedic |
| VICTORY Lumbar Plate System510(k)Oct 31, 2023Orthopedic |
| STRETTO Cable System510(k)Aug 4, 2023Orthopedic |
| Lumbar Expandable lnterbody Spacers -Additional Indications/Implants510(k)Aug 3, 2023Orthopedic |
| HILINE Fixation System510(k)Apr 20, 2023Orthopedic |
| MARVEL Growing Rods510(k)Dec 19, 2022Orthopedic |
| HEDRON Cervical Spacers, HEDRON Lumbar Spacers, SABLE Expandable Spacer, ExcelsiusGPS Instruments510(k)Oct 21, 2022Orthopedic |
| ONVOY Acetabular System510(k)Oct 3, 2022Orthopedic |
| AUTOBAHN(R) EVO Femoral Nails510(k)Sep 9, 2022Orthopedic |
| CAPTIVATE® Compression Screws510(k)Sep 8, 2022Orthopedic |
| InstaFill Graft Delivery System, SIGNIFY Bioactive510(k)Aug 11, 2022General Hospital |
| ANTHEM® Fracture System510(k)Jan 26, 2022Orthopedic |
| Anthem Fracture System510(k)Oct 1, 2021Orthopedic |
| ExcelsiusHub510(k)Aug 25, 2021Neurology |
| QUARTEX Occipito-Cervico-Thoracic Spinal System, Globus Navigation Instruments510(k)Aug 18, 2021Orthopedic |
| Excelsius3D510(k)Aug 12, 2021Radiology |
| Provident II Hip Stems510(k)Jul 14, 2021Orthopedic |
| INDEPENDENCE Spacers, HEDRON IA, MAGNIFY-S Spacers, MONUMENT Spacers, InterContinental Plate-Spacer, ELSA Spacers510(k)Feb 2, 2021Orthopedic |
| CREO Stabilization System, Navigation Instruments, ExcelsiusGPS510(k)Jan 19, 2021Orthopedic |