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This document contains the 510(k) summary and details for the Stryker Consolidated Operating Room Equipment (CORE) System, including its intended use, device specifications, classification, and substantial

How to fill out stryker consolidated operating room

How to fill out Stryker Consolidated Operating Room Equipment (CORE) System 510(k) Summary

1. Start by gathering all necessary information about the Stryker CORE System.
2. Review the FDA guidelines for 510(k) submissions to ensure compliance.
3. Fill out the basic identification information, including the applicant's name and contact details.
4. Provide a description of the Stryker CORE System and its intended use.
5. List the predicate devices that establish substantial equivalence.
6. Include performance data, such as bench testing and any clinical studies.
7. Summarize the labeling and any promotional materials.
8. Ensure all information is accurate and supported by documentation.
9. Submit the 510(k) Summary electronically through the FDA's submission portal.
10. Follow up with the FDA for any additional information requests.

Who needs Stryker Consolidated Operating Room Equipment (CORE) System 510(k) Summary?

1. Medical device manufacturers seeking FDA clearance for the Stryker CORE System.
2. Healthcare facilities planning to incorporate the device in their surgical operations.
3. Regulatory professionals involved in compliance and submissions for medical devices.
4. Surgeons and medical staff who need to understand the operational capabilities of the system.

For pdfFiller’s FAQs

What is Stryker Consolidated Operating Room Equipment (CORE) System 510(k) Summary?

The Stryker Consolidated Operating Room Equipment (CORE) System 510(k) Summary is a document submitted to the FDA that outlines the device's safety and effectiveness, allowing it to be cleared for marketing. It includes information about the product, intended use, technological characteristics, and comparison with predicate devices.

Who is required to file Stryker Consolidated Operating Room Equipment (CORE) System 510(k) Summary?

Manufacturers or authorized representatives who intend to market a medical device that is not exempt from premarket notification are required to file the 510(k) Summary with the FDA.

How to fill out Stryker Consolidated Operating Room Equipment (CORE) System 510(k) Summary?

To fill out the 510(k) Summary, the submitter must provide comprehensive details including the device description, indications for use, technological characteristics, performance testing results, and comparisons with predicate devices, along with relevant labeling information.

What is the purpose of Stryker Consolidated Operating Room Equipment (CORE) System 510(k) Summary?

The purpose of the 510(k) Summary is to demonstrate to the FDA that the Stryker CORE System is safe and effective for its intended use, providing evidence that it is substantially equivalent to a legally marketed predicate device.

What information must be reported on Stryker Consolidated Operating Room Equipment (CORE) System 510(k) Summary?

The information that must be reported includes the device name, intended use, device classification, detailed description, summary of technological characteristics, performance testing data, and labeling, among other relevant details.