Identifiers
- 510(k) Number
- K130396 FDA 510(k)
- FDA Product Code
- MAX FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 888.3080 FDA 510(k)
- Regulation Number
- 888.3080 FDA 510(k)
- Advisory Committee
- Orthopedic FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Rampart O and Rampart P are anterior lumbar interbody fusion devices designed for spinal stabilization. These implants are intended for use in interbody fusion procedures to promote bone growth and maintain disc space height while providing structural support to the lumbar spine. Their design aims to minimize surgical exposure and preserve anatomical integrity during spinal surgery.
The devices are supplied sterile and intended for single-use. They are regulated under FDA 510(k) clearance (K130396) as substantially equivalent to a predicate device, classified under the Orthopedic advisory committee (OR). No specific MRI safety information is provided, and sizes or additional technical specifications are not detailed in the available data.
Frequently asked questions
What are the Rampart O and Rampart P devices used for?
The Rampart O and Rampart P devices are used for interbody fusion procedures to promote bone growth and maintain disc space height while providing structural support to the lumbar spine.
Are the devices supplied sterile and for single-use?
Yes, the devices are supplied sterile and intended for single-use, minimizing the risk of infection and ensuring a safe procedure.
What regulatory clearance do the devices have?
The devices are regulated under FDA 510(k) clearance, classified as substantially equivalent to a predicate device, with clearance number K130396.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Rampart One - Spineology, Spineology® Enters Anterior Fusion Market with Rampart One™ FDA ..., SPINEOLOGY INC. 281-3016 Rampart-O - RevMed, Product-detail | NeuroSpine
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K130396 | Class II | Active |
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Manufacturer
- Manufacturer
- Spineology Inc.
- FDA Applicant
- Spineology, Inc.
Sources (1)
- FDA 510(k) K130396 24 fields · synced Oct 1, 2026