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This document is a 510(k) premarket notification application for the PheniX vertebral body replacement device, detailing its classification, intended uses, and regulatory compliance with the FDA.

How to fill out vertebral body replacement 510k

How to fill out Vertebral Body Replacement 510(k) Application

1. Gather necessary documentation, including device descriptions, intended use, and indications for use.
2. Conduct a literature review to include relevant studies and reports related to vertebral body replacement devices.
3. Perform a risk analysis to identify potential hazards and assess risks associated with the device.
4. Compile performance testing results to demonstrate device safety and effectiveness.
5. Complete the 510(k) application form accurately, ensuring all required information is provided.
6. Include all relevant comparisons to predicate devices, addressing similarities and differences.
7. Review and edit the submission for completeness and regulatory compliance.
8. Submit the application electronically through the FDA's electronic submission gateway.
9. Prepare for potential FDA inquiries and be ready to provide additional information if requested.
10. Monitor the status of the application and respond promptly to any feedback from the FDA.

Who needs Vertebral Body Replacement 510(k) Application?

1. Medical device manufacturers developing vertebral body replacement devices seeking market clearance in the U.S.
2. Healthcare professionals and institutions involved in the procurement of vertebral body replacement devices.
3. Investors and stakeholders interested in the vertebral body replacement market and associated products.
4. Regulatory affairs specialists tasked with navigating FDA processes for medical device approval.

People Also Ask about

What is a vertebral body replacement surgery?

Surgeons may perform a vertebral body replacement from either the side or the back of the spine. During the procedure, he/she will remove and replace the damaged vertebral structures with implants such as cages, screws, plates and/or rods.

What is bone graft vertebral body replacement?

A lumbar vertebral body replacement involves replacing the affected area with a small metal cage filled with bone graft material, which is then into the adjacent healthy vertebrae.

What is a vertebral body replacement surgery?

Surgeons may perform a vertebral body replacement from either the side or the back of the spine. During the procedure, he/she will remove and replace the damaged vertebral structures with implants such as cages, screws, plates and/or rods.

What is the downside of bone graft?

All bone grafting procedures come with risks. They include: Blood loss. Infection.

What is a 510 K application?

The most commonly used path to market for medical devices is called 510(k) Premarket Notification, through which developed receive “clearance” to legally market a new product in the US. To obtain 510(k) clearance, a medical device manufacturer submits a package of documents to FDA for review.

When to submit a 510 k for a change to an existing device?

Manufacturers are required to submit a new 510(k) when a change (or changes) exceeds the 21 CFR 807.81(a)(3) threshold, “could significantly affect the safety or effectiveness of the device,” or constitutes a “major change or modification in the intended use of the device.” This significant effect could be positive or

What is bone graft replacement?

Bone grafting is a surgical procedure that uses transplanted bone to repair and rebuild diseased or damaged bones. A bone graft is a choice for repairing bones almost anywhere in your body. Your surgeon might take bone from your hips, legs, or ribs to perform the graft.

What is a bone graft vertebral body replacement?

A lumbar vertebral body replacement involves replacing the affected area with a small metal cage filled with bone graft material, which is then into the adjacent healthy vertebrae.

For pdfFiller’s FAQs

What is Vertebral Body Replacement 510(k) Application?

The Vertebral Body Replacement 510(k) Application is a premarket submission to the FDA that demonstrates that a medical device intended for replacing a vertebral body is safe and effective and is substantially equivalent to a legally marketed device.

Who is required to file Vertebral Body Replacement 510(k) Application?

Manufacturers of vertebral body replacement devices intending to market their products in the United States are required to file a 510(k) application to obtain FDA clearance.

How to fill out Vertebral Body Replacement 510(k) Application?

To fill out a Vertebral Body Replacement 510(k) Application, manufacturers must complete a form provided by the FDA, including detailed information about the device, its design, materials, intended use, labeling, and safety and efficacy data to demonstrate substantial equivalence.

What is the purpose of Vertebral Body Replacement 510(k) Application?

The purpose of the Vertebral Body Replacement 510(k) Application is to ensure that the device meets regulatory standards established by the FDA for safety and effectiveness, allowing for its legal marketing in the United States.

What information must be reported on Vertebral Body Replacement 510(k) Application?

The application must report information such as the device description, intended use, labeling, manufacturing process, performance testing data, clinical data if applicable, and comparisons to predicate devices to establish substantial equivalence.