Get the free 510(k) Summary K(133966

The Model-Based RSA Software is a standalone analytical software package used by orthopaedic specialists to evaluate metal implant fixation and bone segment motion through in-vivo 3D position measurements. This Windows-based software processes digital roentgen images and assesses the relative motion of implants and bones, aiding in patient treatment decisions.

How to fill out 510k summary k133966

How to fill out 510k summary k133966

1. Identify the Device: Clearly state the name and classification of your device.
2. Manufacturer Information: Provide details about the manufacturer, including name, address, and contact information.
3. Predicate Device Information: List the predicate device to which your device is being compared, including its 510(k) number.
4. Device Description: Offer a detailed description of the device, including its intended use and technology.
5. Intended Use and Indications for Use: Clearly outline the intended use and indications for your device.
6. Substantial Equivalence: Explain how your device is substantially equivalent to the predicate device.
7. Performance Testing: Include data or reports of performance testing, if applicable.
8. Labeling: Provide copies of the proposed labeling for the device, including instructions for use.
9. Risk Analysis: Summarize any risk analysis conducted as per ISO 14971.
10. Summary: Conclude with a summary that emphasizes the safety and effectiveness of the device.

Who needs 510k summary k133966?

1. Manufacturers who are seeking FDA clearance to market a medical device in the United States.
2. Companies that intend to sell devices that are similar to existing, legally marketed devices.
3. Healthcare providers who want to understand the classification of devices they are using.

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What is 510k summary k133966?

510k summary k133966 refers to a specific premarket notification submitted to the FDA, which demonstrates that a device is safe and effective for its intended use through substantial equivalence to a legally marketed device.

Who is required to file 510k summary k133966?

Manufacturers of medical devices that wish to market a new product that is similar to an existing product must file the 510k summary k133966.

How to fill out 510k summary k133966?

To fill out 510k summary k133966, manufacturers must complete the necessary forms required by the FDA, provide detailed information about the device, its intended use, and comparisons to predicate devices, along with any supporting data.

What is the purpose of 510k summary k133966?

The purpose of 510k summary k133966 is to provide the FDA with information to assess whether the new medical device is substantially equivalent to an existing legal device, thereby ensuring its safety and effectiveness.

What information must be reported on 510k summary k133966?

The information that must be reported includes device description, intended use, comparison to predicate devices, labeling, and any relevant safety or effectiveness data.