Search Results

The Vusion™ implants are intended for use in partial spine vertebrectomy procedures for vertebral body replacement. The indications include replacement of a collapsed, damaged, or unstable vertebral body that must be resected or excised due to tumor or trauma. The implants are intended for use with a supplemental rod or plate fixation system.

Not Found

I am sorry, but the provided text does not contain information about acceptance criteria or a study that proves a device meets such criteria. The document is a 510(k) clearance letter from the FDA for a device called "Vusion™ PEEK VBR System," which is a spinal intervertebral body fixation orthosis.

This letter primarily focuses on:

• Device Clearance: Stating that the device is substantially equivalent to legally marketed predicate devices.
• Regulatory Information: Details about regulations (21 CFR 888.3060, Class II, Product Code: MQP).
• Requirements: Reminding the manufacturer of general controls, registration, labeling, good manufacturing practices, etc.
• Indications for Use: Describing the medical conditions for which the device is intended (replacement of collapsed, damaged, or unstable vertebral bodies due to tumor or trauma, used with supplemental fixation).

Therefore, I cannot provide the information requested in the format of acceptance criteria, device performance, sample sizes, ground truth, or study details, as these are not present in the given text.

Ask a specific question about this device