Identifiers
- 510(k) Number
- K192993 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 is a secured lumbar anterior cage designed for spinal fusion procedures. It features a porous titanium structure created using Ti-LIFE Technology, which mimics natural bone to promote cell colonization and optimize medical imaging.
The device is supplied as a single-use, sterile product and is intended for use in lumbar interbody fusion. It is MRI compatible and should be stored in a controlled environment. The device has received FDA 510(k) clearance.
Frequently asked questions
What is the SCARLET AL-T used for?
The SCARLET AL-T is a secured lumbar anterior cage intended for use in spinal fusion procedures. Its porous titanium structure is designed to mimic natural bone, promoting cell colonization and integration.
Is the SCARLET AL-T a single-use device?
Yes, the SCARLET AL-T is supplied as a single-use, sterile product. It is intended for one-time use in a surgical procedure and should not be reused.
How is the SCARLET AL-T stored?
The device should be stored in a controlled environment to maintain its sterility and integrity until it is ready for use.
Is the SCARLET AL-T compatible with MRI imaging?
Yes, the SCARLET AL-T is designed to be MRI compatible, which allows for clear medical imaging after implantation.
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, PDF SCARLET AL-T - neurospineproductreview.com, SCARLET® AL-T - SPINEMarketGroup, Lumbar interbody fusion cage - SCARLET® AL-T - Spineart - anterior
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K192993 | Class II | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Spineart
Sources (1)
- FDA 510(k) K192993 24 fields · synced Sep 25, 2026