Get the free 510(k) Premarket Notification - Accessdata.fda.gov

7 2013FEB 5. 510(K) SUMMARY Submitter\'s Name: Submitter\'s Address:I1_Spectrum Spine IP Holdings, LLC 3045 Paces Lake Court Atlanta, GA 30339Submitter\'s Telephone: Cot came:[Date Summary was Prepared:

How to fill out 510k premarket notification

How to fill out 510k premarket notification

1. Determine if the device requires a 510k premarket notification by checking the FDA classification database.
2. Collect all necessary information and documentation about the device, including design, intended use, and manufacturing process.
3. Complete the 510k submission form and include all required attachments, such as test data and labeling.
4. Submit the 510k premarket notification to the FDA through the electronic submission gateway (ESG) or by mail.
5. Respond to any requests for additional information or clarifications from the FDA reviewer.
6. Await a decision from the FDA on whether the device is cleared for marketing.

Who needs 510k premarket notification?

1. Manufacturers of medical devices that are new, significantly modified, or have a different intended use than previously cleared devices typically need to submit a 510k premarket notification.

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What is 510k premarket notification?

510k premarket notification is a submission made to the FDA to demonstrate that a new medical device is substantially equivalent to a predicate device that is legally marketed.

Who is required to file 510k premarket notification?

Any company intending to market a new medical device in the United States is required to file a 510k premarket notification.

How to fill out 510k premarket notification?

The 510k premarket notification must include detailed information about the new device, comparisons to a legally marketed device, and evidence of safety and efficacy.

What is the purpose of 510k premarket notification?

The purpose of 510k premarket notification is to provide a mechanism for the FDA to review the safety and effectiveness of new medical devices before they are marketed.

What information must be reported on 510k premarket notification?

The 510k premarket notification must include details about the new device, its intended use, labeling, performance data, and any known risks or hazards.