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Atlas Intervertebral Body Cage

by Spinal Edge, LLC

510(k) K092774

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK092774 Date2 Feb 2010ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
MAX
Device Class
Class II
Regulation
21 CFR Part 888.3080
Advisory Committee
Orthopedic
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 22 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The ATLAS INTERVERTEBRAL BODY CAGE is an intervertebral body cage device used to provide structural stability in skeletally mature individuals following corpectomy or vertebrectomy. It is a vertebral body replacement device intended for use in the thoracolumbar spine (T1-L5) to replace a collapsed, damaged or unstable vertebral body due to tumor or trauma.

The device is supplied by Spinal Edge, LLC and has received FDA 510(k) clearance under K092774 with product code MAX. It is classified as a Class II device under regulation 888.3080, with a traditional clearance type and decision of substantially equivalent (SESE). The device is intended for orthopedic use and was cleared on February 2, 2010.

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