Medical device manufacturer
Globus Medical, Inc.
Globus Medical, Inc. holds 172 FDA 510(k) clearances across 37 product codes. Median elapsed review time is 94 days. openFDA lists 29 recall records naming the company. FDA publishes it under 4 different spellings, all counted here as one company.
Updated · ingest status · JSON
- 510(k) clearances
- 172
- Product codes
- 37
- Median review
- 94 days
- Recall records
- 29
How does FDA spell Globus Medical, Inc.?
FDA publishes this company under 4 different spellings across its datasets. Every figure on this page counts all of them as one company, which is why the totals here are higher than a search for any single spelling would give you.
| As FDA published it | Dataset | Matched by |
|---|---|---|
| GLOBUS MEDICAL, INC. | device/registrationlisting | normalised |
| Globus Medical, Inc. | device/510k | normalised |
| Globus Medical, Inc. | device/recall | normalised |
| Globus Medical, Inc. | device/enforcement | normalised |
Merges are measured against a hand-labelled sample and held above 98% precision. Pairs the matcher is unsure of are queued for a person rather than merged, because two genuinely different firms with similar names is the error that would corrupt every count on this page.
Which product codes does Globus Medical, Inc. file in?
37 product codes, ranked by how much they file in each.
| Code | Device | Clearances | Median review | Latest |
|---|---|---|---|---|
| NKB | Thoracolumbosacral Pedicle Screw System | 24 | 67 days | |
| MAX | Intervertebral Fusion Device With Bone Graft, Lumbar | 20 | 145 days | |
| KWQ | Appliance, Fixation, Spinal Intervertebral Body | 15 | 89 days | |
| OLO | Orthopedic Stereotaxic Instrument | 13 | 88 days | |
| MQP | Spinal Vertebral Body Replacement Device | 11 | 57 days | |
| OVD | Intervertebral Fusion Device With Integrated Fixation, Lumbar | 11 | 137 days | |
| HRS | Plate, Fixation, Bone | 8 | 75 days | |
| KWP | Appliance, Fixation, Spinal Interlaminal | 7 | 120 days | |
| MQV | Filler, Bone Void, Calcium Compound | 7 | 181 days | |
| ODP | Intervertebral Fusion Device With Bone Graft, Cervical | 7 | 131 days | |
| NKG | Posterior Cervical Screw System | 4 | 92 days | |
| OVE | Intervertebral Fusion Device With Integrated Fixation, Cervical | 4 | 71 days | |
| HSB | Rod, Fixation, Intramedullary And Accessories | 3 | 186 days | |
| HWC | Screw, Fixation, Bone | 3 | 147 days | |
| LPH | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented | 3 | 298 days | |
| MRW | System, Facet Screw Spinal Device | 3 | 78 days | |
| NQW | Orthosis, Spine, Plate, Laminoplasty, Metal | 3 | 137 days | |
| OWI | Bone Fixation Cerclage, Sublaminar | 3 | 77 days | |
| PEK | Spinous Process Plate | 3 | 53 days | |
| NDN | Cement, Bone, Vertebroplasty | 2 | 125 days | |
| PGM | Growing Rod System | 2 | 67 days | |
| FMF | Syringe, Piston | 1 | 57 days | |
| GCJ | Laparoscope, General & Plastic Surgery | 1 | 252 days | |
| HAW | Neurological Stereotaxic Instrument | 1 | 187 days | |
| HRX | Arthroscope | 1 | 29 days |
Showing the 25 they file in most, of 37.
Median review is elapsed calendar days between date received and decision date, as published by FDA. It is not FDA review days — the two differ whenever the agency stops the clock for an additional information request.
Source: openFDA device/510k · retrieved
Has Globus Medical, Inc. had a recall?
openFDA lists 29 recall records naming this company across its whole history. A recall record covers one firm's corrective action and may span many device lots.
Z-1657-2025Class IIOpen, ClassifiedPGN
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.
Z-1007-2024Class IIOpen, ClassifiedOLO
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.
Z-0995-2024Class IIOpen, ClassifiedHAW
Sterile-packed Cranial Drills may not be sterile due to a breach in the packaging and/or may have discoloration near the drill tip.
Z-0996-2024Class IIOpen, ClassifiedHAW
Sterile-packed Cranial Drills may not be sterile due to a breach in the packaging and/or may have discoloration near the drill tip.
Z-0997-2024Class IIOpen, ClassifiedHAW
Sterile-packed Cranial Drills may not be sterile due to a breach in the packaging and/or may have discoloration near the drill tip.
Showing the 5 most recently initiated of 29.
Recall class comes from openFDA's enforcement endpoint, which does not carry every recall — where it is missing, none is shown rather than guessed. Recall class I is the most serious kind of recall; device class I is the least risky kind of device, and the two are never mixed here.
Source: openFDA device/recall · retrieved
What has Globus Medical, Inc. cleared recently?
| 510(k) | Device | Code | Decision | Elapsed days |
|---|---|---|---|---|
| K253739 | SCRIPT Rods, CREO Stabilization System, REVERE® Stabilization System, REVERE® 4.5 Stabilization System, NuVasive Reline System | NKB | 164 | |
| K253401 | SCRIPT Implant System | OVD | 211 | |
| K261043 | AUTOBAHN Nailing System | HSB | 24 | |
| K252166 | RIB LINK Fixation System | HRS | 231 | |
| K253876 | HEDRON Cervical Spacers (HEDRON C-MIS Spacer) | OVE | 18 | |
| K250599 | ExcelsiusGPS Instruments | OLO | 250 | |
| K251161 | ANTHEM® Fracture System | HRS | 125 | |
| K241525 | ExcelsiusXR | SBF | 404 | |
| K243456 | ONVOY Acetabular System | LPH | 211 | |
| K243814 | NuVasive Pulse System | OLO | 30 |
Source: openFDA device/510k · retrieved
Where is Globus Medical, Inc. registered?
FDA lists 3 registered establishments for this company in US.
Registration means the firm has told FDA it makes or distributes devices from that site. It is not a clearance, an approval or an endorsement.
Watch what Globus Medical, Inc. files next
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Data on this page comes from FDA's public openFDA API and is US public domain (CC0). DeviceSignal is an independent commercial service and is not affiliated with the U.S. Food and Drug Administration. Information only, not regulatory advice. Verify anything you rely on against open.fda.gov.