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K132 886 510(k) Summary of Safety and Effectiveness FEB 4 2014 Smith & Nephew Variable Angle Locking MiniFragment Plating System Submitted By: Smith & Nephew, Inc. Orthopedic Division 1450 Brooks

How to fill out 510k summary of safety

How to fill out 510k summary of safety:

1. Begin by providing a clear and concise title for the summary, indicating the specific medical device or product being evaluated.
2. Include a brief introduction that provides an overview of the regulatory requirements and purpose of the summary.
3. Clearly state the intended use of the medical device, making sure to accurately describe its functions and intended patient population.
4. Describe the device's technological characteristics and provide details on any unique features or materials used.
5. Include a summary of the device's intended performance, specifying key performance indicators or benchmarks.
6. Provide a summary of any clinical data or studies conducted, emphasizing safety-related findings and results.
7. Include a summary of any risk analysis or hazard assessments performed, identifying any potential risks associated with the device.
8. Discuss the device's labeling, including any important warnings, precautions, or contraindications.
9. Provide a summary of any post-market surveillance data or adverse event reports collected for the device.
10. Conclude the summary by reaffirming the device's safety and effectiveness, emphasizing any measures taken to mitigate risks.

Who needs 510k summary of safety?

1. Manufacturers: Medical device manufacturers are required to submit a 510k summary of safety along with their Premarket Notification (510k) application to the U.S. Food and Drug Administration (FDA).
2. Regulatory Agencies: The FDA reviews the 510k summary of safety to assess the safety and effectiveness of the medical device being submitted for clearance.
3. Healthcare Providers: Healthcare providers may refer to the 510k summary of safety to understand the safety profile and potential risks associated with a particular medical device before incorporating it into their practice.
4. Patients: Patients can benefit from reading the 510k summary of safety to gain insights into the safety and performance of the medical device that may be used in their treatment.

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What is 510k summary of safety?

The 510k summary of safety is a document that provides a brief overview of the safety and effectiveness of a medical device.

Who is required to file 510k summary of safety?

Manufacturers of medical devices are required to file the 510k summary of safety with the FDA.

How to fill out 510k summary of safety?

The 510k summary of safety should be filled out with detailed information about the device, its intended use, and any safety testing that has been conducted.

What is the purpose of 510k summary of safety?

The purpose of the 510k summary of safety is to provide the FDA with a summary of the safety and effectiveness data for a medical device.

What information must be reported on 510k summary of safety?

The 510k summary of safety must include information on the device's design, intended use, materials, testing, labeling, and any adverse events that have occurred.