FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Rampart One Lumbar Interbody Fusion Device
K Number: K180002
·
Decision Apr 25, 2018
Classifications
1
FEI Numbers
253
Registration Numbers
253
Same Product Code
200
Applicant Total
54
Review Days
113
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- Rampart One Lumbar Interbody Fusion Device
- K Number
- K180002
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3080
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Spineology, Inc.
- Date Received
- January 2, 2018
- Decision Date
- April 25, 2018
- Product Code
- OVD
- Advisory Committee
- Orthopedic
- 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 |
|---|---|---|---|
| OVD | Intervertebral Fusion Device With Integrated Fixation, Lumbar | FDA class 2 | Orthopedic |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (OVD), ordered by most recent decision date.
Anteralign LS coverplate
FDA 510(k)
FDA Class 2
·Orthopedic
MectaLIF 3D Metal Anterior
FDA 510(k)
FDA Class 2
·Orthopedic
SCRIPT Implant System
FDA 510(k)
FDA Class 2
·Orthopedic
Ventana A Anterior Lumbar Interbody System
FDA 510(k)
FDA Class 2
·Orthopedic
DeGen Medical Patient Specific Implant (PSI) System
FDA 510(k)
FDA Class 2
·Orthopedic
IdentiTi II ALIF Standalone Interbody System; Transcend ALIF Standalone Interbody System
FDA 510(k)
FDA Class 2
·Orthopedic
Other Clearances by Spineology, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K251302 | OptiMesh Multiplanar Expandable Interbody Fusion System | Dec 15, 2025 | Substantially Equivalent |
| K251943 | Spineology Navigation Instruments | Dec 4, 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 |