Rampart L Lumbar Interbody Fusion Device
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K171724 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 L Lumbar Interbody Fusion Device is an intervertebral body fusion device indicated for intervertebral body fusion at one level or two contiguous levels in the lumbar spine from L2 to S1 in patients with degenerative disc disease (DDD) with up to Grade 1 spondylolisthesis at the involved level(s). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by imaging.
The device is supplied as a single implant and may be used for multiple lumbar fusion approaches, including open, MIS TLIF, ultra-MIS (OptiLIF), and endoscopic fusion. It received FDA 510(k) clearance under K171724 and is classified under product code MAX with advisory committee review in orthopedics (OR).
Frequently asked questions
What is the Rampart L Lumbar Interbody Fusion Device used for?
The Rampart L Lumbar Interbody Fusion Device is indicated for intervertebral body fusion at one level or two contiguous levels in the lumbar spine from L2 to S1 in patients with degenerative disc disease (DDD) with up to Grade 1 spondylolisthesis at the involved level(s). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by imaging.
How is the Rampart L Lumbar Interbody Fusion Device supplied?
The device is supplied as a single implant and may be used for multiple lumbar fusion approaches, including open, MIS TLIF, ultra-MIS (OptiLIF), and endoscopic fusion.
What regulatory pathway was used for the Rampart L Lumbar Interbody Fusion Device?
The Rampart L Lumbar Interbody Fusion Device received FDA 510(k) clearance under K171724 and is classified under product code MAX with advisory committee review in orthopedics (OR).
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, Rampart L Lumbar Interbody Fusion Device (K171724) — FDA 510(k ..., Spineology
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K171724 | Class II | Active |
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Manufacturer
- Manufacturer
- Spineology Inc.
- FDA Applicant
- Spineology, Inc.
Sources (1)
- FDA 510(k) K171724 24 fields · synced Sep 25, 2026