Binary Anterior Cervical Plate System

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

510(k) Number

K192076 ↗

FDA Product Code

KWQ

Device Class

Class II

Regulation

21 CFR Part 888.3060

Advisory Committee

Orthopedic

FDA Decision

SESE Substantially Equivalent

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

  The Binary Anterior Cervical Plate System is designed for temporary stabilization of the cervical spine during anterior spinal fusion procedures. It provides structural support to the cervical vertebrae in cases of degenerative disc disease, spondylolisthesis, or traumatic cervical spine injuries. The modular plate and locking screws ensure secure fixation while accommodating varying anatomical needs.

• How is the Binary Anterior Cervical Plate System supplied and prepared for use?

  The system is supplied as a sterile, single-use device, intended exclusively for operating room use by trained surgeons. It must remain sterile until immediate preoperative use. The modular design includes plates with integrated locking mechanisms and self-drilling, self-tapping screws in fixed and variable configurations, ensuring ease of placement without additional tools.

• What screw sizes are included in the Binary Anterior Cervical Plate System?

  The system features primary screws with a diameter of 3.75mm and recovery screws with a diameter of 4.25mm. These screws are designed to secure the plate to the cervical vertebrae, providing stable fixation during spinal fusion procedures. The modular nature of the system allows for customizable screw placement to match anatomical requirements.

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

  The Binary Anterior Cervical Plate System is explicitly designed as a single-use device. This ensures sterility and safety for each patient, reducing the risk of cross-contamination or device degradation from repeated use. Single-use devices are also aligned with best practices for orthopedic implants in surgical settings.

• Are there any special storage requirements for the Binary Anterior Cervical Plate System?

  The system must be stored in a manner that maintains sterility until immediate preoperative use. No specific storage conditions (e.g., temperature or humidity) are mentioned beyond ensuring the packaging remains intact. Since it is single-use, it should not be reused or restocked after opening. Proper handling prevents contamination and ensures compliance with surgical protocols.