Atlantis Anterior Cervical Plate System

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

510(k) Number

K993855 ↗

FDA Product Code

KWQ

Device Class

Class II

Regulation

21 CFR Part 888.3060

Advisory Committee

Orthopedic

FDA Decision

SESE Substantially Equivalent

• Modification of Tsrh Spinal System

  Class II

  FDA 510(k) K984522 Active Cleared 6 Jan 1999

• Overhead Arm Slings

  Class I

  FDA 510(k) K823811 Active Cleared 14 Jan 1983

• Cd Horizon Spinal System

  Class II

  FDA 510(k) K993810 Active Cleared 3 Feb 2000

• Danek Precision Rod Set

  Class II

  FDA 510(k) K896254 Active Cleared 14 Jun 1990

• Spine Fixation

  Class II

  FDA 510(k) K943827 Active Cleared 14 Feb 1996

• Modification of the Zplate-Atl Anterior Fixation System

  Class II

  FDA 510(k) K990603 Active Cleared 10 Mar 1999

See all devices from Danek Medical, Inc. →

• What is the Atlantis Anterior Cervical Plate System used for?

  The Atlantis Anterior Cervical Plate System is used for anterior interbody screw fixation of the cervical spine, providing resistance to graft displacement and maintaining anterior cervical alignment.

• What are the components of the Atlantis Anterior Cervical Plate System?

  The system is supplied with various components, but specific details are not provided. It is recommended to consult the manufacturer or product documentation for a comprehensive list.

• Is the Atlantis Anterior Cervical Plate System authorized for use?

  The Atlantis Anterior Cervical Plate System has been authorized with FDA 510K clearance, indicating that it has been found to be substantially equivalent to other devices on the market.

• What testing standards has the Atlantis Anterior Cervical Plate System been evaluated against?

  The device has been tested following ASTM testing standards and has been found to perform equal to or better than other systems.