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Scarlet AC-Ti

FDA 510(k)

Class II (US FDA 510(k))

510(k) K240699

by SpineArt SA

Identifiers

510(k) Number
K240699 FDA 510(k)
FDA Product Code
OVE 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 AC-Ti is an intervertebral fusion device with integrated fixation designed for the cervical spine. It is a 3D printed titanium secured anterior cervical cage that features Ti-LIFE technology, which provides a porous, interconnected structure intended to replicate trabecular bone geometry.

This device is supplied as a Class II medical device and has received FDA 510(k) clearance. It is designed to provide an anatomical fit between vertebral endplates and includes a lordotic option of 7 degrees.

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® AC-Ti - Spineart, SCARLET® AC-T - Spineart, PDF SCARLET AC-T i - neurospineproductreview.com, K240699 FDA 510 (k) - SCARLET AC-Ti | Spineart SA

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
SpineArt SA

Sources (1)

  • FDA 510(k) K240699 24 fields · synced Sep 24, 2026