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This document provides a summary of 510(k) safety and effectiveness information for the Inflatable Bone Tamp. It includes details about the device, intended use, classification, technological characteristics,

How to fill out traditional 510k inflatable bone

How to fill out Traditional 510(k): Inflatable Bone Tamp

1. Gather necessary documentation including device description, indications for use, and comparator device information.
2. Prepare a summary of the device's technological characteristics and performance testing results.
3. Complete the FDA 510(k) application form, providing accurate and detailed information.
4. Include labeling information and any advertising materials.
5. Pay the required user fee as per the FDA guidelines.
6. Submit the completed 510(k) application electronically through the FDA's Center for Devices and Radiological Health (CDRH) portal.
7. Respond promptly to any requests for additional information from the FDA during the review process.

Who needs Traditional 510(k): Inflatable Bone Tamp?

1. Medical device manufacturers seeking to market an inflatable bone tamp.
2. Healthcare providers looking for regulatory-approved devices for bone augmentation procedures.
3. Patients requiring safe and effective solutions for orthopedic treatments.

People Also Ask about

What does a bone tamp do?

The procedure involves insertion of an inflatable bone tamp to elevate end plates. This restores the vertebral body back to its original height and creates a cavity to be filled with a bone cement. There is potential for intraprocedural loss of vertebral height as the balloon deflates.

What is an inflatable splint?

THE INFLATABLE plastic splint, which surrounds the extremity including the digits, is a good first aid measure for the immobilization of fractures but, when applied with an air pressure exceeding certain limits, may occlude the lumen of the small blood vessels of the digits.

What bone cement is used in kyphoplasty?

The two main groups of bone cement are acrylic bone cement and calcium phosphate bone cement. Mostly they are used either in vertebroplasty or kyphoplasty procedures.

What is an inflatable bone tamp?

It is designed to compress cancellous bone and/or move cortical bone as it inflates. The Inflatable Bone Tamp has a nominal length of 40 cm and consists of a double lumen catheter shaft constructed from two coaxially aligned tubings. The inflatable component is mounted near the distal tip of the catheter tubing.

What are the FDA 510k regulations?

Overview of Section 510(k) Section 510(k) of the Food, Drug and Cosmetic Act requires device manufacturers who must register, to notify FDA of their intent to market a medical device at least 90 days in advance. This is known as Premarket Notification - also called PMN or 510(k).

What is bone kyphoplasty?

Kyphoplasty is performed on patients who experience vertebral compression fractures resulting from osteoporosis. During the procedure, a balloon tamp is inserted into the fractured vertebra and inflated. By creating a space where the fractured bone was and may restore the vertebra to its proper height and shape.

For pdfFiller’s FAQs

What is Traditional 510(k): Inflatable Bone Tamp?

The Traditional 510(k): Inflatable Bone Tamp is a premarket submission made to the FDA to demonstrate that a medical device is safe and effective for use. It specifically refers to a device designed to provide structural support in orthopedic procedures by using an inflatable mechanism to facilitate the stabilization of bone fractures.

Who is required to file Traditional 510(k): Inflatable Bone Tamp?

Manufacturers of the Inflatable Bone Tamp are required to file a Traditional 510(k) if they intend to market the device in the United States. This includes new manufacturers or those introducing significant changes to an existing device.

How to fill out Traditional 510(k): Inflatable Bone Tamp?

To fill out a Traditional 510(k) for an Inflatable Bone Tamp, manufacturers must complete the required forms, provide a description of the device, compare it to similar devices already on the market, include labeling information, and furnish any supporting data such as clinical studies or performance testing results to demonstrate safety and efficacy.

What is the purpose of Traditional 510(k): Inflatable Bone Tamp?

The purpose of the Traditional 510(k) submission for an Inflatable Bone Tamp is to obtain FDA clearance to market the device. It allows the manufacturer to demonstrate that the device is substantially equivalent to a legally marketed device in terms of safety and effectiveness.

What information must be reported on Traditional 510(k): Inflatable Bone Tamp?

The Traditional 510(k) submission must report information such as the device's name, a detailed device description, intended use, substantial equivalence comparisons, design details, manufacturing processes, labeling, and any scientific evidence supporting its safety and effectiveness.