Rampart A Lumbar Interbody Fusion Device
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K153082 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 A Lumbar Interbody Fusion Device is an intervertebral body fusion implant designed for spinal stabilization. It is classified as an interbody fusion device under FDA product code MAX, intended for use in lumbar spine procedures. The device is engineered to facilitate bone fusion between vertebrae while maintaining structural integrity and alignment. Its design supports interbody fusion at one or two contiguous levels from L2 to S1, addressing degenerative disc pathology with minimal surgical exposure.
This device is supplied sterile and intended for single-use. It is cleared for use in the orthopedic setting under FDA 510(k) clearance (K153082) as substantially equivalent to predicate devices. The device is not MRI-safe; caution must be exercised in imaging due to metallic components. Storage and handling follow standard sterile orthopedic implant protocols, and its dimensions are standardized for lumbar interbody applications. No additional regulatory markings beyond the FDA clearance are stated.
Frequently asked questions
What is the Rampart A Lumbar Interbody Fusion Device used for?
The Rampart A Lumbar Interbody Fusion Device is designed to facilitate bone fusion between adjacent vertebrae in the lumbar spine (from L2 to S1). It addresses degenerative disc pathology by providing structural support and maintaining spinal alignment during the fusion process. The device is intended for use in procedures where one or two contiguous levels require stabilization, helping restore stability with minimal surgical exposure.
How is the Rampart A device supplied and intended for use?
The Rampart A Lumbar Interbody Fusion Device is supplied sterile and is intended for single-use only. This ensures patient safety by preventing cross-contamination and maintains the device’s integrity for optimal performance during spinal fusion procedures. Single-use also aligns with standard orthopedic implant protocols to minimize infection risks.
Is the Rampart A device MRI-safe?
No, the Rampart A Lumbar Interbody Fusion Device is not MRI-safe due to its metallic components. If MRI imaging is required post-surgery, caution must be exercised to avoid potential artifacts or interference that could compromise diagnostic accuracy. Always consult imaging guidelines for metallic implants before scheduling scans.
What storage and handling protocols should be followed for the Rampart A device?
The Rampart A device must be stored and handled according to standard sterile orthopedic implant protocols. This includes maintaining sterility until use, protecting it from contamination, and adhering to manufacturer guidelines for packaging integrity. Improper storage could compromise the device’s sterility or structural integrity, risking surgical complications.
What regulatory clearance does the Rampart A device hold?
The Rampart A Lumbar Interbody Fusion Device holds FDA 510(k) clearance (K153082) under the Orthopedic advisory committee, classified as substantially equivalent to predicate devices. This clearance confirms its compliance with U.S. regulatory standards for interbody fusion implants intended for lumbar spine procedures. No additional regulatory markings beyond this clearance are specified.
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, PDF Rampart™ One Lumbar Interbody Fusion Device MRI WARNI, K163670 - Rampart One Lumbar Interbody Fusion Device, Rampart A Lumbar Interbody Fusion Device (K153082) — FDA 510(k ...
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K153082 | Class II | Active |
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Manufacturer
- Manufacturer
- Spineology Inc.
- FDA Applicant
- Spineology, Inc.
Sources (1)
- FDA 510(k) K153082 24 fields · synced Oct 1, 2026