Get U2 Hip System - Accessdata Fda

Filling out the U2 Hip System form can seem daunting at first, but this guide breaks down each section to simplify the process. By following these steps, you can ensure that your submission is complete and accurate.

Follow the steps to successfully complete the U2 Hip System form.

1. Press the ‘Get Form’ button to access the U2 Hip System form and open it in your browser.
2. Provide your contact information in the designated fields. This typically includes your name, company, address, phone number, and email. Ensure that this information is accurate as it will be used for any follow-up communication.
3. Fill in the proprietary name and common name of the device. In this case, the proprietary name is 'U2 Hip System' and the common name is 'semi-constrained total hip prostheses'.
4. Indicate the classification of the device. It is classified as a Class II device under the Orthopedic panel.
5. In the section for device description, detail the components of the U2 Hip System that you are submitting. Include specifics about the titanium porous coated cup, cup liner, femoral head sizes, and stem options.
6. Outline the indications for use, specifying the conditions the device is intended to treat, such as painful joint diseases or revision surgeries.
7. Complete the section on substantial equivalence, listing the predicate devices the U2 Hip System is compared to, and describe how it is similar in features and functionality.
8. Review the performance tests section to ensure all relevant mechanical tests have been documented accurately. This will include test results demonstrating the system's durability and safety.
9. Finalize your submission by reviewing all sections for completeness and accuracy. Once confirmed, save your changes, and proceed to download, print, or share the completed form as needed.

Start filling out your U2 Hip System form online today to ensure a smooth submission process.