Globus Medical, Inc.
Audubon, PA, US
GLOBUS MEDICAL, INC. appears in FDA device records in Audubon, PA. FDA records list 217 510(k) clearances between and , 12 PMA records and 3 registered establishments. As of , FDA records show 42 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
FDA records under these names
1 nameFDA records resolved to Globus Medical, Inc. carry these names as well, as FDA wrote them. Each is the firm named on a registration, a 510(k), a PMA, a recall or an enforcement report that was joined to this company on a shared FDA identifier or on a matching name.
- Stelkast, Inc.510(k), PMA, enforcement report, recall
510(k) clearance history
Showing 50 of 217FDA records hold 217 510(k) clearances for Globus Medical, Inc. between 1994 and 2026. The busiest year on record is 2018, with 15. The most recent is 2026, with 6.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1994 | 4 |
| 1995 | 6 |
| 1996 | 3 |
| 1997 | 3 |
| 1998 | 2 |
| 1999 | 1 |
| 2000 | 6 |
| 2001 | 2 |
| 2002 | 2 |
| 2003 | 5 |
| 2004 | 5 |
| 2005 | 5 |
| 2006 | 5 |
| 2007 | 5 |
| 2008 | 11 |
| 2009 | 11 |
| 2010 | 4 |
| 2011 | 11 |
| 2012 | 11 |
| 2013 | 11 |
| 2014 | 5 |
| 2015 | 4 |
| 2016 | 9 |
| 2017 | 13 |
| 2018 | 15 |
| 2019 | 14 |
| 2020 | 4 |
| 2021 | 7 |
| 2022 | 7 |
| 2023 | 4 |
| 2024 | 10 |
| 2025 | 6 |
| 2026 | 6 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K254043 | TRIVANCE™ Hip Stem | LPH | Substantially Equivalent | |
| K262251 | ACTIFY™ Total Knee System, ACTIFY™ 3D Total Knee System (ACTIFY MC Tibial Insert) | JWH | Substantially Equivalent | |
| K253739 | SCRIPT™ Rods, CREO™ Stabilization System, REVERE® Stabilization System, REVERE® 4.5 Stabilization System, NuVasive Reline™ System | NKB | Substantially Equivalent | |
| K253401 | SCRIPT™ Implant System | OVD | Substantially Equivalent | |
| K261043 | AUTOBAHN™ Nailing System | HSB | Substantially Equivalent | |
| K252166 | RIB LINK™ Fixation System | HRS | Substantially Equivalent | |
| K253876 | HEDRON™ Cervical Spacers (HEDRON C-MIS™ Spacer) | OVE | Substantially Equivalent | |
| K250599 | ExcelsiusGPS™ Instruments | OLO | Substantially Equivalent | |
| K251161 | ANTHEM® Fracture System | HRS | Substantially Equivalent | |
| K241525 | ExcelsiusXR™ | SBF | Substantially Equivalent | |
| K243456 | ONVOY™ Acetabular System | LPH | Substantially Equivalent | |
| K243814 | NuVasive Pulse System | OLO | Substantially Equivalent | |
| K243671 | ExcelsiusGPS® Instruments | OLO | Substantially Equivalent | |
| K241260 | ACTIFY™ Unicondylar Knee System | HSX | Substantially Equivalent | |
| K234035 | COSINE™ Spacer | MAX | Substantially Equivalent | |
| K240669 | ACTIFY™ 3D Total Knee System, ACTIFY™ Total Knee System | JWH | Substantially Equivalent | |
| K240721 | ExcelsiusFlex™ | OLO | Substantially Equivalent | |
| K240947 | TENSOR® Suture Button System | HTN | Substantially Equivalent | |
| K240568 | DuraPro™ Oscillating System | OLO | Substantially Equivalent | |
| K231850 | QUARTEX® Occipito-Cervico-Thoracic Spinal System ExcelsiusGPS® Instruments | NKG | Substantially Equivalent | |
| K233638 | VERZA™ High Speed Drills | OLO | Substantially Equivalent | |
| K233735 | ADIRA™ Lateral Plate System | KWQ | Substantially Equivalent | |
| K232318 | VICTORY™ Lumbar Plate System | KWQ | Substantially Equivalent | |
| K231333 | STRETTO™ Cable System | JDQ | Substantially Equivalent | |
| K221894 | Lumbar Expandable lnterbody Spacers -Additional Indications/Implants | MAX | Substantially Equivalent | |
| K230565 | HILINE™ Fixation System | OWI | Substantially Equivalent | |
| K213196 | MARVEL™ Growing Rods | PGM | Substantially Equivalent | |
| K222270 | HEDRON Cervical Spacers, HEDRON Lumbar Spacers, SABLE Expandable Spacer, ExcelsiusGPS Instruments | ODP | Substantially Equivalent | |
| K213842 | ONVOY Acetabular System | LPH | Substantially Equivalent | |
| K220659 | AUTOBAHN(R) EVO Femoral Nails | HSB | Substantially Equivalent | |
| K222409 | CAPTIVATE® Compression Screws | HWC | Substantially Equivalent | |
| K221737 | InstaFill Graft Delivery System, SIGNIFY Bioactive | FMF | Substantially Equivalent | |
| K213591 | ANTHEM® Fracture System | HRS | Substantially Equivalent | |
| K212433 | Anthem Fracture System | HRS | Substantially Equivalent | |
| K211616 | ExcelsiusHub | OLO | Substantially Equivalent | |
| K211957 | QUARTEX Occipito-Cervico-Thoracic Spinal System, Globus Navigation Instruments | NKG | Substantially Equivalent | |
| K210912 | Excelsius3D | OWB | Substantially Equivalent | |
| K201733 | Provident II Hip Stems | LPH | Substantially Equivalent | |
| K203278 | INDEPENDENCE Spacers, HEDRON IA, MAGNIFY-S Spacers, MONUMENT Spacers, InterContinental Plate-Spacer, ELSA Spacers | MAX | Substantially Equivalent | |
| K203153 | CREO Stabilization System, Navigation Instruments, ExcelsiusGPS | NKB | Substantially Equivalent | |
| K202496 | ANTHEM Fracture System | HRS | Substantially Equivalent | |
| K201087 | CORBEL Spacers | OVD | Substantially Equivalent | |
| K200047 | ExcelsiusGPS Cranial 1.0 Module | OLO | Substantially Equivalent | |
| K192115 | SABLE Expandable Spacer | MAX | Substantially Equivalent | |
| K192744 | CORRIDOR Fixation System | MRW | Substantially Equivalent | |
| K192314 | RESONATE Anterior Cervical Plate System | KWQ | Substantially Equivalent | |
| K191391 | HEDRON Lumbar Spacers | MAX | Substantially Equivalent | |
| K191243 | HEDRON Cervical Spacers | ODP | Substantially Equivalent | |
| K191835 | CREO Stabilization System, Navigation Instruments, ExcelsiusGPS Instruments | NKB | Substantially Equivalent | |
| K191100 | ExcelsiusGPS Spine 1.1 Interbody Module | OLO | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3004142400 | 3004142400 | GLOBUS MEDICAL, INC. | 2560 General Armistead Ave, AUDUBON, PA 19403 US | 2026 | and 76 more, listed in full below |
| 3011713200 | 3011713200 | GLOBUS MEDICAL, INC. | 300 GRIFFIN BROOK DRIVE, Methuen, MA 01844 US | 2026 | |
| 3030412764 | 3030412764 | GLOBUS MEDICAL, INC. | 4670 E. SHELBY DR, Memphis, TN 38118 US | 2026 | and 67 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- CACApparatus, Autotransfusion
- KTTAppliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
- LXTAppliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, Metal Composite
- KWPAppliance, Fixation, Spinal Interlaminal
- KWQAppliance, Fixation, Spinal Intervertebral Body
- HRXArthroscope
- HTWBit, Drill
- HTQBroach
- GFFBur, Surgical, General & Plastic Surgery
- KTZCaliper
- JQCCentrifuges (Micro, Ultra, Refrigerated) For Clinical Use
- JDQCerclage, Fixation
- BSKCuff, Tracheal Tube, Inflatable
- JDODevice, Fixation, Proximal Femoral, Implant
- HWRDriver, Prosthesis
- IKNElectromyograph, Diagnostic
- GEIElectrosurgical, Cutting & Coagulation & Accessories
- HWBExtractor
- IFPFormalin, Neutral Buffered
- HTJGauge, Depth
- HWAImpactor
- HWEInstrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment
- ITQJoint, Knee, External Brace
- GCJLaparoscope, General & Plastic Surgery
- FSTLight, Surgical, Fiberoptic
- FTLMesh, Surgical, Polymeric
- JDZMixer, Cement, For Clinical Use
- GEYMotor, Surgical Instrument, Ac-Powered
- JDSNail, Fixation, Bone
- HAWNeurological Stereotaxic Instrument
- LXHOrthopedic Manual Surgical Instrument
- HRSPlate, Fixation, Bone
- KWIProsthesis, Elbow, Hemi-, Radial, Polymer
- JDGProsthesis, Hip, Femoral Component, Cemented, Metal
- KWLProsthesis, Hip, Hemi-, Femoral, Metal
- KWYProsthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented
- JDIProsthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
- LPHProsthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
- LWJProsthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented
- HSXProsthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer
- JWHProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
- KWTProsthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented
- HTOReamer
- GADRetractor
- HSBRod, Fixation, Intramedullary And Accessories
- HWCScrew, Fixation, Bone
- HXXScrewdriver
- GKTSeparator, Automated, Blood Cell, Diagnostic
- GWFStimulator, Electrical, Evoked Response
- ETNStimulator, Nerve
- BXMStimulator, Nerve, Ac-Powered
- INKStretcher, Wheeled, Powered
- FMFSyringe, Piston
- LLZSystem, Image Processing, Radiological
- JAASystem, X-Ray, Fluoroscopic, Image-Intensified
- JEBTable, Surgical With Orthopedic Accessories, Manual
- HWTTemplate
- BTRTube, Tracheal (W/Wo Connector)
- HTNWasher, Bolt Nut
- HXCWrench
Recall records
Showing 25 of 42| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-1657-2025 | MAGEC 2 Rod, 5.0mm 90mm Standard; Version/Model: MC2-5090S; | Devices for the affected lot were not assembled according to product specifications. The distraction rod outer diameter was assembled with a 5.5mm rod versus the required 5.0mm. | Class II | Open, Classified | |
| Z-1007-2024 | ExcelsiusGPS Cannula A, 9mm x 250mm, Cannula used with ball tip probes, Model No. 6143.2844 | Devices may not be rendered sterile due to an internal gap that may be present on some devices causing increased difficulty cleaning prior to steam sterilization. There is an increased risk for infection, inflammation, local toxicity, systemic toxicity, sensitivity, and cross-contamination. | Class II | Open, Classified | |
| Z-0997-2024 | Globus Medical Cranial Drill, 6.00mm - instruments for access, preparation, and placement of cranial devices with the ExcelsiusGPS. Ref: 6143.1870S | Sterile-packed Cranial Drills may not be sterile due to a breach in the packaging and/or may have discoloration near the drill tip. | Class II | Open, Classified | |
| Z-0996-2024 | Globus Medical Cranial Drill with Stop, 3.20mm - instruments for access, preparation, and placement of cranial devices with the ExcelsiusGPS. Ref: 6143.1842S | Sterile-packed Cranial Drills may not be sterile due to a breach in the packaging and/or may have discoloration near the drill tip. | Class II | Open, Classified | |
| Z-0995-2024 | Globus Medical Cranial Drill with Stop, 2.40mm - Instruments for access, preparation, and placement of cranial devices with the ExcelsiusGPS. Ref : 6143.1834S | Sterile-packed Cranial Drills may not be sterile due to a breach in the packaging and/or may have discoloration near the drill tip. | Class II | Open, Classified | |
| Z-0642-2024 | ExcelsiusGPS Flat Panel Fluoroscopy Fixture Kit, Part number 6203.2100 | A calibration error associated with the Flat Panel Fluoroscopy Fixture when used with ExcelsiusGPS for fluoroscopy workflow may lead to inaccurate navigation, which may result in device misplacement. | Class I | Open, Classified | |
| Z-2871-2020 | ALTERA Spacer ALTERA Spacer, 10x36, 12-16mm, 15 | Specific lots of ALTERA implants have internal components that may have been manufactured using stainless steel rather than the specified cobalt chromium molybdenum alloy. | Class II | Terminated | |
| Z-2870-2020 | ALTERA Spacer ALTERA Spacer, 10x36, 10-14mm, 15 | Specific lots of ALTERA implants have internal components that may have been manufactured using stainless steel rather than the specified cobalt chromium molybdenum alloy. | Class II | Terminated | |
| Z-2869-2020 | ALTERA Spacer ALTERA Spacer, 10x36, 9-13mm, 15 | Specific lots of ALTERA implants have internal components that may have been manufactured using stainless steel rather than the specified cobalt chromium molybdenum alloy. | Class II | Terminated | |
| Z-2868-2020 | ALTERA Spacer ALTERA Spacer, 10x36, 12-16mm, 8 | Specific lots of ALTERA implants have internal components that may have been manufactured using stainless steel rather than the specified cobalt chromium molybdenum alloy. | Class II | Terminated | |
| Z-2867-2020 | ALTERA Spacer ALTERA Spacer, 10x36, 10-14mm, 8 | Specific lots of ALTERA implants have internal components that may have been manufactured using stainless steel rather than the specified cobalt chromium molybdenum alloy. | Class II | Terminated | |
| Z-2866-2020 | ALTERA Spacer ALTERA Spacer, 10x36, 9-13mm, 8 | Specific lots of ALTERA implants have internal components that may have been manufactured using stainless steel rather than the specified cobalt chromium molybdenum alloy. | Class II | Terminated | |
| Z-2865-2020 | ALTERA Spacer ALTERA Spacer, 10x36, 8-12mm, 8 | Specific lots of ALTERA implants have internal components that may have been manufactured using stainless steel rather than the specified cobalt chromium molybdenum alloy. | Class II | Terminated | |
| Z-2864-2020 | ALTERA Spacer ALTERA Spacer, 10x31, 12-16mm, 15 | Specific lots of ALTERA implants have internal components that may have been manufactured using stainless steel rather than the specified cobalt chromium molybdenum alloy. | Class II | Terminated | |
| Z-2863-2020 | ALTERA Spacer ALTERA Spacer, 10x31, 10-14mm, 15 | Specific lots of ALTERA implants have internal components that may have been manufactured using stainless steel rather than the specified cobalt chromium molybdenum alloy. | Class II | Terminated | |
| Z-2862-2020 | ALTERA Spacer ALTERA Spacer, 10x31, 9-13mm, 15 | Specific lots of ALTERA implants have internal components that may have been manufactured using stainless steel rather than the specified cobalt chromium molybdenum alloy. | Class II | Terminated | |
| Z-2861-2020 | ALTERA Spacer ALTERA Spacer, 10x31, 12-16mm, 8 | Specific lots of ALTERA implants have internal components that may have been manufactured using stainless steel rather than the specified cobalt chromium molybdenum alloy. | Class II | Terminated | |
| Z-2860-2020 | ALTERA Spacer ALTERA Spacer, 10x31, 10-14mm, 8 | Specific lots of ALTERA implants have internal components that may have been manufactured using stainless steel rather than the specified cobalt chromium molybdenum alloy. | Class II | Terminated | |
| Z-2859-2020 | ALTERA Spacer ALTERA Spacer, 10x31, 9-13mm, 8 | Specific lots of ALTERA implants have internal components that may have been manufactured using stainless steel rather than the specified cobalt chromium molybdenum alloy. | Class II | Terminated | |
| Z-2858-2020 | ALTERA Spacer ALTERA Spacer, 10x31, 8-12mm, 8 | Specific lots of ALTERA implants have internal components that may have been manufactured using stainless steel rather than the specified cobalt chromium molybdenum alloy. | Class II | Terminated | |
| Z-2857-2020 | ALTERA Spacer ALTERA Spacer, 10x26, 12-16mm, 15 | Specific lots of ALTERA implants have internal components that may have been manufactured using stainless steel rather than the specified cobalt chromium molybdenum alloy. | Class II | Terminated | |
| Z-2856-2020 | ALTERA Spacer ALTERA Spacer, 10x26, 10-14mm, 15 | Specific lots of ALTERA implants have internal components that may have been manufactured using stainless steel rather than the specified cobalt chromium molybdenum alloy. | Class II | Terminated | |
| Z-2855-2020 | ALTERA Spacer ALTERA Spacer, 10x26, 9-13mm, 15 | Specific lots of ALTERA implants have internal components that may have been manufactured using stainless steel rather than the specified cobalt chromium molybdenum alloy. | Class II | Terminated | |
| Z-2854-2020 | ALTERA Spacer ALTERA Spacer, 10x26, 12-16mm, 8 | Specific lots of ALTERA implants have internal components that may have been manufactured using stainless steel rather than the specified cobalt chromium molybdenum alloy. | Class II | Terminated | |
| Z-2853-2020 | ALTERA Spacer ALTERA Spacer, 10x26, 10-14mm, 8 | Specific lots of ALTERA implants have internal components that may have been manufactured using stainless steel rather than the specified cobalt chromium molybdenum alloy. | Class II | Terminated |
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Data as of , FDA export datePage updated Source: openFDA, public domain