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Atlas Spine Vertebral Body Replacement

FDA 510(k)

Class II (US FDA 510(k))

510(k) K063464

by Atlas Spine, Inc.

Identifiers

510(k) Number
K063464 FDA 510(k)
FDA Product Code
MQP FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 888.3060 FDA 510(k)
Regulation Number
888.3060 FDA 510(k)
Advisory Committee
Orthopedic FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Atlas Spine Vertebral Body Replacement is a device intended for use in the thoracolumbar spine (T1-L5) for partial or complete replacement (i.e., vertebrectomy) of a diseased vertebral body resected or excised for the treatment of tumors. It is designed to achieve anterior decompression of the spinal cord and neural tissues and to restore vertebral height.

The device is supplied as an implant and is indicated for use in surgical procedures involving vertebral body replacement. It received FDA 510(k) clearance (K063464) on March 9, 2007, and is classified under product code MQP with an orthopedic advisory committee review. The device is manufactured by Atlas Spine, Inc. and is authorized for distribution in the United States.

Frequently asked questions

What is the Atlas Spine Vertebral Body Replacement used for?

It is intended for use in the thoracolumbar spine (T1-L5) for partial or complete replacement of a diseased vertebral body resected or excised for the treatment of tumors, achieving anterior decompression of the spinal cord and neural tissues and restoring vertebral height.

How is the Atlas Spine Vertebral Body Replacement supplied?

The device is supplied as an implant for use in surgical procedures involving vertebral body replacement, as indicated in its labeling and intended use.

Is the Atlas Spine Vertebral Body Replacement a single-use device?

While the device data does not explicitly state single-use or reuse, it is supplied as an implant intended for surgical implantation, which implies it is designed for single-patient use during a surgical procedure.

What regulatory pathway was used for the Atlas Spine Vertebral Body Replacement?

The device received FDA 510(k) clearance (K063464) on March 9, 2007, and was found substantially equivalent to a predicate device under product code MQP with orthopedic advisory committee review.

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: HOME | Atlas Spine, ATLAS SPINE VERTEBRAL BODY REPLACEMENT - Innolitics, Atlas Spine, Inc. FDA 510(k) Orthopedic Products - Latest 2026

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) K063464 24 fields · synced Sep 27, 2026