Search Results

The CoFix System is a posterior, non-pedicle supplemental fixation device intended for use with an interbody cage as an adjunct to fusion at a single level in the lumbar spine (L1-S1). It is intended for attachment to the spinous processes for the purpose of achieving stabilization to promote fusion in patients with degenerative disc disease – defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies - with up to Grade 1 spondylolisthesis.

The CoFix System is an implant system for interlaminar/interspinous fixation within lumbar interbody fusion surgery. It consists of a single, U-shaped component, fabricated from medical grade titanium alloy (Ti6Al4V). A set of two wings extends vertically from the superior long arm of the device, with a second set of wings extending below the inferior long arm. A screw and sleeve are inserted through a prepared hole and fixes the crimped wings to the superior and inferior spinous processes.

The purpose of this Special 510(k) is to modify the CoFix Sterilization Tray , which is manufactured from stainless steel. The modifications do not affect the intended use of the device or alter the fundamental scientific technology of the device. The CoFix sterilization tray is intended to hold and protect the system's instruments during transport, storage, and steam sterilization.

The actual therapeutic effect is achieved by the CoFix implants.

This document is a 510(k) premarket notification decision letter from the FDA regarding the CoFix System, a medical device for spinal fixation. It primarily addresses the sterilization tray for the device, not the AI component of a device. Therefore, it does not contain the information needed to answer your questions about acceptance criteria for AI performance, sample sizes for AI training/test sets, expert adjudication, or MRMC studies.

The document states: "The purpose of this Special 510(k) is to modify the CoFix Sterilization Tray, which is manufactured from stainless steel. The modifications do not affect the intended use of the device or alter the fundamental scientific technology of the device."

The "Performance Testing Summary" section describes testing related to sterilization, not to the performance of the CoFix implant itself or any AI component.

Therefore, I cannot provide the requested information based on this document.

Ask a specific question about this device