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Incite Anchored Cervical Interbody (ACI) Fusion Device

FDA 510(k)

Class II (US FDA 510(k))

510(k) K122008

by Incite Innovation, LLC

Identifiers

510(k) Number
K122008 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 Incite Anchored Cervical Interbody (ACI) Fusion Device is a spinal spacer designed to maintain intervertebral spacing and angulation in the cervical spine. It is indicated for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one disc level from C2-T1, where DDD is defined as discogenic pain with disc degeneration confirmed by history and radiographic studies.

The device is implanted via an open anterior approach by surgeons and requires supplemental anterior cervical plate fixation. It provides structural support for fusion using autogenous bone graft. The device is supplied non-sterile and is intended for single-use. It has received FDA 510(k) clearance under k-number K122008 and product code OVE.

Frequently asked questions

What is the Incite Anchored Cervical Interbody (ACI) Fusion Device used for?

The device is used to maintain intervertebral spacing and angulation in the cervical spine for skeletally mature patients with degenerative disc disease (DDD) at one disc level from C2-T1 who have radicular symptoms, providing structural support for fusion when used with autogenous bone graft and supplemental anterior cervical plate fixation.

How is the Incite ACI Fusion Device supplied and is it reusable?

The device is supplied non-sterile and is intended for single-use only; it must be sterilized by the user before implantation and is not designed for reuse due to material degradation and contamination risks after one surgical procedure.

What sizes or models are available for the Incite ACI Fusion Device?

The device data does not specify particular sizes, models, or reference numbers beyond the product name; therefore, no dimensional or variant details can be provided from the available information.

What regulatory pathway was used for the Incite ACI Fusion Device?

The device received FDA 510(k) clearance under k-number K122008 and product code OVE, determined to be substantially equivalent to a predicate device through a traditional review process.

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: European Innovation Centre for Industrial Transformation and Emissions, Incite Anchored Cervical Interbody (Aci) Fusion Device, INCITE ANCHORED CERVICAL INTERBODY DEVICE (K130306) — FDA 510(k ...

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Incite Innovation, LLC

Sources (1)

  • FDA 510(k) K122008 24 fields · synced Oct 6, 2026