Identifiers
- 510(k) Number
- K181818 FDA 510(k)
- FDA Product Code
- OVD 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 Scarlet AL-T Ti-Life Secured Lumbar Anterior Cage is a spinal interbody fusion device designed for anterior lumbar interbody fusion procedures. Constructed using Ti-Life Technology, it features a porous titanium structure that mimics natural bone, facilitating cellular colonization and optimizing radiographic imaging. This device is classified as an orthopedic interbody fusion cage under the FDA’s product code OVD (Orthopedic Devices, Spinal Fusion Systems).
The Scarlet AL-T Ti-Life is supplied as a reusable surgical implant, intended for single-patient use per sterile packaging. It includes three integrated screw channels for secure screw placement, a self-drilling screw design with quadri threads, and a zero-profile one-step locking mechanism to prevent screw migration. The device is cleared under the FDA’s 510(k) pathway (K181818) as substantially equivalent to a predicate device, with manufacturing oversight by Spineart in Plan-les-Ouates, Switzerland. Sterility and regulatory compliance are ensured through FDA-authorized processes.
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: SCARLET® AL-T - Spineart, SCARLET® AL-T - SPINEMarketGroup, PDF SCARLET AL-T - neurospineproductreview.com, PDF SCARLET AL-T - tinanew.ahmadhayek.com
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K181818 | Class II | Active |
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Manufacturer
- Manufacturer
- Spineart
Sources (1)
- FDA 510(k) K181818 24 fields · synced Oct 1, 2026