FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Spineology Navigation Instruments
K Number: K251943
·
Decision Dec 4, 2025
Classifications
1
FEI Numbers
381
Registration Numbers
381
Same Product Code
430
Applicant Total
54
Review Days
163
Basic Information
- Device Name
- Spineology Navigation Instruments
- K Number
- K251943
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 882.4560
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Spineology, Inc.
- Date Received
- June 24, 2025
- Decision Date
- December 4, 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 |
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Other Clearances by Spineology, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K251302 | OptiMesh Multiplanar Expandable Interbody Fusion System | Dec 15, 2025 | Substantially Equivalent |
| K230927 | OptiMesh Multiplanar Expandable Interbody Fusion System | Nov 1, 2023 | Substantially Equivalent |
| K231781 | OptiMesh Multiplanar Expandable Interbody Fusion System | Oct 18, 2023 | Substantially Equivalent |
| K213876 | Spineology Navigation Instruments | Aug 5, 2022 | Substantially Equivalent |
| K210155 | Duo Expandable Interbody Fusion System | Feb 19, 2021 | Substantially Equivalent |
| DEN200010 | Spineology Interbody Fusion System | Sep 18, 2020 | Unknown |
| K192047 | Rampart One Lumbar Interbody Fusion System | Aug 23, 2019 | Substantially Equivalent |
| K191091 | Rampart One Lumbar Interbody Fusion System | May 23, 2019 | Substantially Equivalent |
| K190055 | Duo Lumbar Interbody Fusion Device | Mar 7, 2019 | Substantially Equivalent |
| K182322 | Duo Lumbar Interbody Fusion Device | Oct 24, 2018 | Substantially Equivalent |