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This document provides a summary of the 510(k) submission for the Zimmer Patient Specific Instruments System, outlining its intended use, regulatory compliance, product characteristics, and equivalence

How to fill out 510k summary for zimmer

How to fill out 510(k) Summary for Zimmer Patient Specific Instruments

1. Gather all necessary product information, including device description and intended use.
2. Identify the predicate device that your Zimmer Patient Specific Instruments are based on.
3. Prepare a table comparing the technological characteristics of your device with the predicate device.
4. Conduct and document any performance testing or clinical evaluations to support safety and effectiveness.
5. Write a detailed summary of the non-clinical and clinical data, including results and conclusions.
6. Include any risk analysis and mitigation strategies relevant to your device.
7. Ensure that all formats are in accordance with FDA guidelines for 510(k) submissions.
8. Review the summary for accuracy and completeness before submission.

Who needs 510(k) Summary for Zimmer Patient Specific Instruments?

1. Manufacturers of Zimmer Patient Specific Instruments that intend to market the device in the USA.
2. Medical professionals and healthcare facilities intending to use these specific instruments and requiring regulatory compliance.
3. Regulatory bodies that need to assess the safety and efficacy of the devices prior to approval.

People Also Ask about

What is the 510k section of the Federal Food, Drug and Cosmetic Act?

A 510(k) is a premarket submission made to FDA to demonstrate that the device to be marketed is as safe and effective, that is, substantially equivalent, to a legally marketed device (section 513(i)(1)(A) FD&C Act).

What is the difference between FDA and FDA 510k?

The Primary Difference Between FDA And FDA 510k The main distinction between the FDA vs FDA 510(k) is that the FDA oversees total product safety, whereas FDA 510(k) is a premarket submission procedure for medical device clearance based on equivalence.

What is premarket notification 510 k?

A 510(k) Premarket Notification is required for low to moderate risk medical devices classified as either Class I or Class II and not exempt from 510(k). Companies are unable to market their products to health care providers, patients and other consumers until they are given 510(k) clearance by the FDA.

What is the FDA brief summary requirement?

The law requires that print ads making claims about a drug (product claim ads) include a "brief summary" with all the risks listed in the drug's "prescribing information" and at least one FDA-approved use of the drug. The brief summary generally includes: Who should not take the drug.

What is the FDA 510k summary?

Overview of Section 510(k) This allows FDA to determine whether the device is equivalent to a device already placed into one of the three classification categories. Thus, "new" devices (not in commercial distribution prior to May 28, 1976) that have not been classified can be properly identified.

What is the 510k FDA summary?

Overview of Section 510(k) This allows FDA to determine whether the device is equivalent to a device already placed into one of the three classification categories. Thus, "new" devices (not in commercial distribution prior to May 28, 1976) that have not been classified can be properly identified.

What is a 510k device number?

A 510(k) is a premarket submission made to the FDA. It is called a 510(k) because it refers to that section of the Food, Drug and Cosmetic Act. It is the regulatory pathway mostly utilized for Class II devices that hope to be substantially equivalent to another device which is currently legally marketed.

What is 510 K to the FDA?

A 510(k) is a premarket submission made to FDA to demonstrate that the device to be marketed is as safe and effective, that is, substantially equivalent, to a legally marketed device (section 513(i)(1)(A) FD&C Act).

For pdfFiller’s FAQs

What is 510(k) Summary for Zimmer Patient Specific Instruments?

The 510(k) Summary for Zimmer Patient Specific Instruments is a premarket submission to the FDA that demonstrates that these medical devices are safe and effective based on substantial equivalence to a legally marketed device.

Who is required to file 510(k) Summary for Zimmer Patient Specific Instruments?

Manufacturers of Zimmer Patient Specific Instruments are required to file a 510(k) Summary if they intend to market a new device that is substantially equivalent to an existing device already marketed in the U.S.

How to fill out 510(k) Summary for Zimmer Patient Specific Instruments?

To fill out the 510(k) Summary for Zimmer Patient Specific Instruments, manufacturers need to provide detailed information about the device, including its intended use, technological characteristics, labeling, and data supporting its safety and efficacy.

What is the purpose of 510(k) Summary for Zimmer Patient Specific Instruments?

The purpose of the 510(k) Summary is to provide the FDA with enough information to determine whether the Zimmer Patient Specific Instruments are substantially equivalent to a predicate device, ensuring safety and effectiveness for patients.

What information must be reported on 510(k) Summary for Zimmer Patient Specific Instruments?

The 510(k) Summary must report information such as the device name, classification, description, intended use, substantial equivalence claim, and any relevant performance testing data, as well as any labeling claims.