Rampart T Lumbar Interbody Fusion Device
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K163409 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 T Lumbar Interbody Fusion Device is a lumbar interbody fusion cage designed for use in the lumbar spine. It functions as an integrated intervertebral body fusion device to facilitate fusion at one or two contiguous levels.
This device is indicated for use in patients with degenerative disc disease at levels L2 to S1, including those with up to Grade I spondylolisthesis. It has received FDA 510k clearance for clinical use.
Frequently asked questions
What is the intended use of the Rampart T Lumbar Interbody Fusion Device?
This device is designed as an integrated intervertebral body fusion cage to facilitate spinal fusion. It is specifically indicated for patients diagnosed with degenerative disc disease at levels L2 through S1, including cases involving up to Grade I spondylolisthesis.
At which spinal levels can the Rampart T device be utilized?
The device is indicated for use in the lumbar spine at levels L2 to S1. It is designed to facilitate fusion at one or two contiguous levels within this specific region of the spine.
Has the Rampart T Lumbar Interbody Fusion Device received regulatory clearance?
Yes, the Rampart T Lumbar Interbody Fusion Device has received FDA 510k clearance for clinical use. This indicates that the device has been reviewed and found to be substantially equivalent to legally marketed predicate devices.
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: Lumbar interbody fusion cage - Rampart™ T - Spineology - MedicalExpo, Rampart One - Spineology, PDF Rampart™ One Lumbar Interbody Fusion Device MRI WARNI
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K163409 | Class II | Active |
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Manufacturer
- Manufacturer
- Spineology Inc.
- FDA Applicant
- Spineology, Inc.
Sources (1)
- FDA 510(k) K163409 24 fields · synced Sep 21, 2026