Company · US
Globus Medical, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 2003 to 2026. Name variants (Inc, Corp, punctuation) are merged.
175510(k) clearances (8 in 12 months)
29recalls (0 in 12 months)
29recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| MAX | Intervertebral Fusion Device With Bone Graft, Lumbar | 42 |
| NKB | Thoracolumbosacral Pedicle Screw System | 24 |
| KWQ | Appliance, Fixation, Spinal Intervertebral Body | 15 |
| OLO | Orthopedic Stereotaxic Instrument | 15 |
| MQP | Spinal Vertebral Body Replacement Device | 11 |
| OVD | Intervertebral Fusion Device With Integrated Fixation, Lumbar | 11 |
| HRS | Plate, Fixation, Bone | 9 |
| MQV | Filler, Bone Void, Calcium Compound | 8 |
| KWP | Appliance, Fixation, Spinal Interlaminal | 7 |
| ODP | Intervertebral Fusion Device With Bone Graft, Cervical | 7 |
| HAW | Neurological Stereotaxic Instrument | 4 |
| LPH | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented | 4 |
| NKG | Posterior Cervical Screw System | 4 |
| OVE | Intervertebral Fusion Device With Integrated Fixation, Cervical | 4 |
| HSB | Rod, Fixation, Intramedullary And Accessories | 3 |
| HWC | Screw, Fixation, Bone | 3 |
| MRW | System, Facet Screw Spinal Device | 3 |
| NQW | Orthosis, Spine, Plate, Laminoplasty, Metal | 3 |
| OWI | Bone Fixation Cerclage, Sublaminar | 3 |
| PEK | Spinous Process Plate | 3 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Oct 23, 2026 | K262779 | ANTHEM Fracture System Globus Medical, Inc. | HRS |
| Aug 4, 2026 | K254043 | TRIVANCE Hip Stem Globus Medical, Inc. | LPH |
| Jul 31, 2026 | K262251 | ACTIFY Total Knee System, ACTIFY 3D Total Knee System (ACTIFY MC Tibial Insert) Globus Medical, Inc. | JWH |
| May 7, 2026 | K253739 | SCRIPT Rods, CREO Stabilization System, REVERE® Stabilization System, REVERE® 4.5 Stabilization System, NuVasive Reli Globus Medical, Inc. | NKB |
| Apr 29, 2026 | K253401 | SCRIPT Implant System Globus Medical, Inc. | OVD |
| Apr 24, 2026 | K261043 | AUTOBAHN Nailing System Globus Medical, Inc. | HSB |
| Feb 26, 2026 | K252166 | RIB LINK Fixation System Globus Medical, Inc. | HRS |
| Dec 22, 2025 | K253876 | HEDRON Cervical Spacers (HEDRON C-MIS Spacer) Globus Medical, Inc. | OVE |
| Nov 5, 2025 | K250599 | ExcelsiusGPS Instruments Globus Medical, Inc. | OLO |
| Aug 18, 2025 | K251161 | ANTHEM® Fracture System Globus Medical, Inc. | HRS |
| Jul 8, 2025 | K241525 | ExcelsiusXR Globus Medical, Inc. | SBF |
| Jun 6, 2025 | K243456 | ONVOY Acetabular System Globus Medical, Inc. | LPH |
| Jan 10, 2025 | K243814 | NuVasive Pulse System Globus Medical, Inc. | OLO |
| Dec 20, 2024 | K243671 | ExcelsiusGPS® Instruments Globus Medical, Inc. | OLO |
| Dec 6, 2024 | K241260 | ACTIFY Unicondylar Knee System Globus Medical, Inc. | HSX |
| Sep 6, 2024 | K234035 | COSINE Spacer Globus Medical, Inc. | MAX |
| Jun 20, 2024 | K240669 | ACTIFY 3D Total Knee System, ACTIFY Total Knee System Globus Medical, Inc. | JWH |
| Jun 14, 2024 | K240721 | ExcelsiusFlex Globus Medical, Inc. | OLO |
| Jun 3, 2024 | K240947 | TENSOR® Suture Button System Globus Medical, Inc. | HTN |
| Apr 29, 2024 | K240568 | DuraPro Oscillating System Globus Medical, Inc. | OLO |
| Mar 14, 2024 | K231850 | QUARTEX® Occipito-Cervico-Thoracic Spinal System ExcelsiusGPS® Instruments Globus Medical, Inc. | NKG |
| Feb 9, 2024 | K233638 | VERZA High Speed Drills Globus Medical, Inc. | OLO |
| Jan 25, 2024 | K233735 | ADIRA Lateral Plate System Globus Medical, Inc. | KWQ |
| Oct 31, 2023 | K232318 | VICTORY Lumbar Plate System Globus Medical, Inc. | KWQ |
| Aug 4, 2023 | K231333 | STRETTO Cable System Globus Medical, Inc. | JDQ |
| Aug 3, 2023 | K221894 | Lumbar Expandable lnterbody Spacers -Additional Indications/Implants Globus Medical, Inc. | MAX |
| Apr 20, 2023 | K230565 | HILINE Fixation System Globus Medical, Inc. | OWI |
| Dec 19, 2022 | K213196 | MARVEL Growing Rods Globus Medical, Inc. | PGM |
| Oct 21, 2022 | K222270 | HEDRON Cervical Spacers, HEDRON Lumbar Spacers, SABLE Expandable Spacer, ExcelsiusGPS Instruments Globus Medical, Inc. | ODP |
| Oct 3, 2022 | K213842 | ONVOY Acetabular System Globus Medical, Inc. | LPH |
| Sep 9, 2022 | K220659 | AUTOBAHN(R) EVO Femoral Nails Globus Medical, Inc. | HSB |
| Sep 8, 2022 | K222409 | CAPTIVATE® Compression Screws Globus Medical, Inc. | HWC |
| Aug 11, 2022 | K221737 | InstaFill Graft Delivery System, SIGNIFY Bioactive Globus Medical, Inc. | FMF |
| Jan 26, 2022 | K213591 | ANTHEM® Fracture System Globus Medical, Inc. | HRS |
| Oct 1, 2021 | K212433 | Anthem Fracture System Globus Medical, Inc. | HRS |
| Aug 25, 2021 | K211616 | ExcelsiusHub Globus Medical, Inc. | OLO |
| Aug 18, 2021 | K211957 | QUARTEX Occipito-Cervico-Thoracic Spinal System, Globus Navigation Instruments Globus Medical, Inc. | NKG |
| Aug 12, 2021 | K210912 | Excelsius3D Globus Medical, Inc. | OWB |
| Jul 14, 2021 | K201733 | Provident II Hip Stems Globus Medical, Inc. | LPH |
| Feb 2, 2021 | K203278 | INDEPENDENCE Spacers, HEDRON IA, MAGNIFY-S Spacers, MONUMENT Spacers, InterContinental Plate-Spacer, ELSA Spacers Globus Medical, Inc. | MAX |
| Jan 19, 2021 | K203153 | CREO Stabilization System, Navigation Instruments, ExcelsiusGPS Globus Medical, Inc. | NKB |
| Oct 29, 2020 | K202496 | ANTHEM Fracture System Globus Medical, Inc. | HRS |
| Jul 31, 2020 | K201087 | CORBEL Spacers Globus Medical, Inc. | OVD |
| Jul 10, 2020 | K200047 | ExcelsiusGPS Cranial 1.0 Module Globus Medical, Inc. | OLO |
| Jan 14, 2020 | K192115 | SABLE Expandable Spacer Globus Medical, Inc. | MAX |
| Dec 16, 2019 | K192744 | CORRIDOR Fixation System Globus Medical, Inc. | MRW |
| Oct 23, 2019 | K192314 | RESONATE Anterior Cervical Plate System Globus Medical, Inc. | KWQ |
| Sep 18, 2019 | K191391 | HEDRON Lumbar Spacers Globus Medical, Inc. | MAX |
| Sep 17, 2019 | K191243 | HEDRON Cervical Spacers Globus Medical, Inc. | ODP |
| Aug 6, 2019 | K191835 | CREO Stabilization System, Navigation Instruments, ExcelsiusGPS Instruments Globus Medical, Inc. | NKB |
Newest 50 of 175.
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 23, 2025 | Globus Medical, Inc. MAGEC 2 Rod, 5.0mm 90mm Standard; Version/Model: MC2-5090S; Open, Classified |
PGN | K171791 |
| Feb 7, 2024 | Globus Medical, Inc. ExcelsiusGPS Cannula A, 9mm x 250mm, Cannula used with ball tip probes, Model No. 6143.2844 Open, Classified |
OLO | K171651 |
| Feb 6, 2024 | Globus Medical, Inc. Globus Medical Cranial Drill, 6.00mm - instruments for access, preparation, and placement of cranial devices with the ExcelsiusGPS.
Ref: 6143.1870S Open, Classified |
HAW | K200047 |
| Feb 6, 2024 | Globus Medical, Inc. Globus Medical Cranial Drill with Stop, 3.20mm - instruments for access, preparation, and placement of cranial devices with the ExcelsiusGPS.
Ref: 6143.1842S Open, Classified |
HAW | K200047 |
| Feb 6, 2024 | Globus Medical, Inc. Globus Medical Cranial Drill with Stop, 2.40mm - Instruments for access, preparation, and placement of cranial devices with the ExcelsiusGPS.
Ref : 6143.1834S Open, Classified |
HAW | K200047 |
| Jan 18, 2024 | Globus Medical, Inc. ExcelsiusGPS Flat Panel Fluoroscopy Fixture Kit, Part number 6203.2100 Open, Classified |
OLO | K211616 |
| Aug 22, 2020 | Globus Medical, Inc. ALTERA Spacer
ALTERA Spacer, 10x36, 12-16mm, 15 Terminated |
MAX | K140411 |
| Aug 22, 2020 | Globus Medical, Inc. ALTERA Spacer
ALTERA Spacer, 10x36, 10-14mm, 15 Terminated |
MAX | K140411 |
| Aug 22, 2020 | Globus Medical, Inc. ALTERA Spacer
ALTERA Spacer, 10x36, 9-13mm, 15 Terminated |
MAX | K140411 |
| Aug 22, 2020 | Globus Medical, Inc. ALTERA Spacer
ALTERA Spacer, 10x36, 12-16mm, 8 Terminated |
MAX | K140411 |
| Aug 22, 2020 | Globus Medical, Inc. ALTERA Spacer
ALTERA Spacer, 10x36, 10-14mm, 8 Terminated |
MAX | K140411 |
| Aug 22, 2020 | Globus Medical, Inc. ALTERA Spacer
ALTERA Spacer, 10x36, 9-13mm, 8 Terminated |
MAX | K140411 |
| Aug 22, 2020 | Globus Medical, Inc. ALTERA Spacer
ALTERA Spacer, 10x36, 8-12mm, 8 Terminated |
MAX | K140411 |
| Aug 22, 2020 | Globus Medical, Inc. ALTERA Spacer
ALTERA Spacer, 10x31, 12-16mm, 15 Terminated |
MAX | K140411 |
| Aug 22, 2020 | Globus Medical, Inc. ALTERA Spacer
ALTERA Spacer, 10x31, 10-14mm, 15 Terminated |
MAX | K140411 |
| Aug 22, 2020 | Globus Medical, Inc. ALTERA Spacer
ALTERA Spacer, 10x31, 9-13mm, 15 Terminated |
MAX | K140411 |
| Aug 22, 2020 | Globus Medical, Inc. ALTERA Spacer
ALTERA Spacer, 10x31, 12-16mm, 8 Terminated |
MAX | K140411 |
| Aug 22, 2020 | Globus Medical, Inc. ALTERA Spacer
ALTERA Spacer, 10x31, 10-14mm, 8 Terminated |
MAX | K140411 |
| Aug 22, 2020 | Globus Medical, Inc. ALTERA Spacer
ALTERA Spacer, 10x31, 9-13mm, 8 Terminated |
MAX | K140411 |
| Aug 22, 2020 | Globus Medical, Inc. ALTERA Spacer
ALTERA Spacer, 10x31, 8-12mm, 8 Terminated |
MAX | K140411 |
| Aug 22, 2020 | Globus Medical, Inc. ALTERA Spacer
ALTERA Spacer, 10x26, 12-16mm, 15 Terminated |
MAX | K140411 |
| Aug 22, 2020 | Globus Medical, Inc. ALTERA Spacer
ALTERA Spacer, 10x26, 10-14mm, 15 Terminated |
MAX | K140411 |
| Aug 22, 2020 | Globus Medical, Inc. ALTERA Spacer
ALTERA Spacer, 10x26, 9-13mm, 15 Terminated |
MAX | K140411 |
| Aug 22, 2020 | Globus Medical, Inc. ALTERA Spacer
ALTERA Spacer, 10x26, 12-16mm, 8 Terminated |
MAX | K140411 |
| Aug 22, 2020 | Globus Medical, Inc. ALTERA Spacer
ALTERA Spacer, 10x26, 10-14mm, 8 Terminated |
MAX | K140411 |
| Aug 22, 2020 | Globus Medical, Inc. ALTERA Spacer
ALTERA Spacer, 10x26, 9-13mm, 8 Terminated |
MAX | K140411 |
| Aug 22, 2020 | Globus Medical, Inc. ALTERA Spacer
ALTERA Spacer, 10x26, 8-12mm, 8 Terminated |
MAX | K140411 |
| Aug 22, 2020 | Globus Medical, Inc. ALTERA Spacer
ALTERA Spacer, 10x31, 8-12mm, 8 (sterile) Terminated |
MAX | K140411 |
| Oct 31, 2013 | Globus Medical, Inc. Globus Medical MicroFuse Putty, 2.5cc and 10cc.
Product Usage:
MicroFuse Bone Void Filler is indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. Micro Terminated |
MQV | K102392 |