Anterior Cervical Plate System

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

510(k) Number

K001847 ↗

FDA Product Code

KWQ

Device Class

Class II

Regulation

21 CFR Part 888.3060

Advisory Committee

Orthopedic

FDA Decision

SESE Substantially Equivalent

• 6.5 Mm Cancellous Bone Screw

  Class II

  FDA 510(k) K931665 Active Cleared 17 Feb 1994

• Berlin External Fixator

  Class II

  FDA 510(k) K954053 Active Cleared 16 May 1996

• Modification to Isobar Spinal System

  Class II

  FDA 510(k) K000020 Active Cleared 3 Feb 2000

• Foundation Knee Augmentation Blocks

  Class II

  FDA 510(k) K941306 Active Cleared 8 Feb 1995

• Foundation Porous Coated Hemispherical Shell

  Class II

  FDA 510(k) K974093 Active Cleared 28 Jan 1998

• Press-Fit Porous Shell

  Class II

  FDA 510(k) K961526 Active Cleared 17 Sep 1996

See all devices from Encore Orthopedics, Inc. →

• What is the Anterior Cervical Plate System used for?

  The Anterior Cervical Plate System is designed for surgical spinal fixation in the cervical spine. It provides internal support by securing titanium plates to adjacent vertebral bodies, helping stabilize the spine during procedures like fusion or trauma repair. The system includes punched plates, eye-type screws, and a braided cable for enhanced fixation, ensuring proper alignment and immobilization of the cervical vertebrae.

• Is the Anterior Cervical Plate System reusable or single-use?

  This system is intended for single-use only. It is supplied sterile to ensure patient safety and prevent contamination. Reuse could compromise sterility and integrity, potentially leading to infection or device failure. Always follow manufacturer guidelines for handling and disposal after a single surgical procedure.

• What materials is the Anterior Cervical Plate System made from?

  The system is primarily constructed from titanium, a biocompatible material known for its strength and corrosion resistance. Titanium is commonly used in spinal implants due to its ability to integrate well with bone tissue while maintaining structural stability. The punched plates, screws, and braided cable are all designed to work together for secure fixation.

• How should the Anterior Cervical Plate System be stored?

  To maintain sterility and integrity, the system must be stored according to the manufacturer’s instructions. Typically, this involves keeping it in its original packaging in a clean, dry environment away from direct sunlight or extreme temperatures. Avoid opening the sterile barrier until immediately before use, and ensure the packaging remains uncompromised to prevent contamination.

• Can the Anterior Cervical Plate System be used with MRI imaging?

  No, the Anterior Cervical Plate System is not MRI-safe. The presence of metallic components, such as titanium plates and screws, can interfere with MRI scans and pose risks to patients and equipment. Always confirm imaging compatibility with radiology staff before scheduling any MRI procedures involving this device.