FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ExcelsiusGPS Instruments
K Number: K250599
·
Decision Nov 5, 2025
Classifications
1
FEI Numbers
381
Registration Numbers
381
Same Product Code
430
Applicant Total
172
Review Days
250
Basic Information
- Device Name
- ExcelsiusGPS Instruments
- K Number
- K250599
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 882.4560
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Globus Medical, Inc.
- Date Received
- February 28, 2025
- Decision Date
- November 5, 2025
- Product Code
- OLO
- Advisory Committee
- Neurology
- Review Advisory Committee
- OR
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| OLO | Orthopedic Stereotaxic Instrument | FDA class 2 | Neurology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (OLO), ordered by most recent decision date.
Dynamis Robotic Surgical System
FDA 510(k)
FDA Class 2
·Neurology
CORUS Navigation System-GN
FDA 510(k)
FDA Class 2
·Neurology
SIMPACT Sacroiliac Joint Fixation System GX Navigation Instruments
FDA 510(k)
FDA Class 2
·Neurology
Navigated LLIF Impactable Tracker
FDA 510(k)
FDA Class 2
·Neurology
CROSSNAV Navigation Enabled Instruments for Disc Preparation and Interbody
FDA 510(k)
FDA Class 2
·Neurology
Ion-C Navigation Instruments
FDA 510(k)
FDA Class 2
·Neurology
Other Clearances by Globus Medical, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K253739 | SCRIPT Rods, CREO Stabilization System, REVERE® Stabilization System, REVERE® 4.5 Stabilization System, NuVasive Reline System | May 7, 2026 | Substantially Equivalent |
| K253401 | SCRIPT Implant System | Apr 29, 2026 | Substantially Equivalent |
| K261043 | AUTOBAHN Nailing System | Apr 24, 2026 | Substantially Equivalent |
| K252166 | RIB LINK Fixation System | Feb 26, 2026 | Substantially Equivalent |
| K253876 | HEDRON Cervical Spacers (HEDRON C-MIS Spacer) | Dec 22, 2025 | Substantially Equivalent |
| K251161 | ANTHEM® Fracture System | Aug 18, 2025 | Substantially Equivalent |
| K241525 | ExcelsiusXR | Jul 8, 2025 | Substantially Equivalent |
| K243456 | ONVOY Acetabular System | Jun 6, 2025 | Substantially Equivalent |
| K243814 | NuVasive Pulse System | Jan 10, 2025 | Substantially Equivalent |
| K243671 | ExcelsiusGPS® Instruments | Dec 20, 2024 | Substantially Equivalent |