FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
iGPS Navigation Instruments
K Number: K251780
·
Decision Sep 15, 2025
Classifications
1
FEI Numbers
381
Registration Numbers
381
Same Product Code
430
Applicant Total
32
Review Days
97
Basic Information
- Device Name
- iGPS Navigation Instruments
- K Number
- K251780
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 882.4560
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- SI-BONE, Inc.
- Date Received
- June 10, 2025
- Decision Date
- September 15, 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 SI-BONE, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K253488 | iFuse INTRA Ti Implant System | Feb 11, 2026 | Substantially Equivalent |
| K253094 | iFuse Bedrock Granite Implant System | Oct 9, 2025 | Substantially Equivalent |
| K241504 | iFuse TORQ TNT Implant System | Aug 19, 2024 | Substantially Equivalent |
| K241574 | iFuse TORQ® Implant System | Jul 2, 2024 | Substantially Equivalent |
| K232800 | Navigation Tracking Instruments | Feb 23, 2024 | Substantially Equivalent |
| K233508 | iFuse Bedrock Granite® Implant System | Jan 26, 2024 | Substantially Equivalent |
| K231689 | iFuse TORQ® Implant System | Jun 30, 2023 | Substantially Equivalent |
| K222774 | iFuse Bedrock Granite® Implant System | Dec 22, 2022 | Substantially Equivalent |
| K222605 | iFuse TORQ® Implant System | Sep 29, 2022 | Substantially Equivalent |
| K213667 | iFuse-TORQ® Implant System | Jun 10, 2022 | Substantially Equivalent |