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The Perfix™ Spinal System is a posterior, noncervical pedicle fixation system intended to provide immobilization and stabilization of spinal segments in skeletallymature patients as an adjunct to fusion by autogenous bone graft in the treatment of the following acute and chronic instabilities or deformities of thoracic, lumbar and sacral spine:

• · Spondylolisthesis (Grade 3 and 4)
• · Degenerative spondylolisthesis with objective evidence of neurological impairment
• · Trauma (i.e., fracture or dislocation)
• · Spinal stenosis
• · Deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis)
• · Tumor
• · Pseudoarthrosis
• · Failed previous fusion

The Perfix™ Spinal System is manufactured by U&I corporation. The Perfix™ is a top-loading multiple component, posterior spinal fixation system which consists of pedicle screws, rods, set screws, connectors, and a transverse (cross) linking mechanism. The Perfix™ Spinal System allows surgeons to build a spinal implant construct to stabilize and promote spinal fusion. The Penfix™ implant system components are supplied non-sterile, single use and are fabricated from titanium alloy (Ti-6Al-4V ELI) in accordance with ASTM F136.

This document describes a spinal fixation system, not an AI/ML powered device. As such, the requested information regarding acceptance criteria, study details, expert involvement, and ground truth establishment, which are typical for AI/ML device evaluations, are not applicable to the "Perfix™ Spinal System".

The provided text details the device's classification, intended use, and substantial equivalence to a predicate device, which are standard components of a 510(k) submission for a traditional medical device. It does not contain any information about software, algorithms, or AI/ML components.

Therefore, I cannot provide the requested information.

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