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Atlas Spine Expandable Cervical Interbody System

FDA 510(k)

Class II (US FDA 510(k))

510(k) K180675

by Atlas Spine, Inc.

Identifiers

510(k) Number
K180675 FDA 510(k)
FDA Product Code
ODP 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 Atlas Spine Expandable Cervical Interbody System is an expandable cervical interbody fusion device intended for anterior cervical interbody fusion. It is designed for use in patients with cervical disc degeneration and/or cervical spinal instability, as confirmed by imaging studies, resulting in radiculopathy and/or pain at multiple contiguous levels.

The device is supplied as a sterile, single-use implant system. It is indicated for use in the cervical spine and has received FDA 510(k) clearance under product code ODP, with K-number K180675. The system is manufactured by Atlas Spine, Inc. and is intended for surgical implantation in anterior cervical procedures.

Frequently asked questions

What is the Atlas Spine Expandable Cervical Interbody System used for?

It is intended for anterior cervical interbody fusion in patients with cervical disc degeneration and/or cervical spinal instability confirmed by imaging, which results in radiculopathy and/or pain at multiple contiguous levels.

How is the Atlas Spine Expandable Cervical Interbody System supplied and is it reusable?

The device is supplied as a sterile, single-use implant system, meaning each component is sterilized and designed for one surgical procedure only; it is not intended for cleaning, resterilization, or reuse.

What regulatory pathway was used for the Atlas Spine Expandable Cervical Interbody System?

The system received FDA 510(k) clearance under product code ODP with K-number K180675, indicating it was found substantially equivalent to a legally marketed predicate device.

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: HiJAK AC - Atlas Spine, HOME | Atlas Spine, Atlas Spine Expandable Cervical Interbody System

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Atlas Spine, Inc.

Sources (1)

  • FDA 510(k) K180675 24 fields · synced Sep 27, 2026