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This document provides a summary of the regulatory submission for the Apex ARC™ Hip Stem, a medical device intended for use in hip replacement surgeries. It outlines the device's specifications,
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How to fill out 510k summary k090845
How to fill out 510(k) SUMMARY K090845
01
Visit the FDA website and access the 510(k) submission page.
02
Download the 510(k) SUMMARY K090845 template.
03
Fill out your device's general information including name, manufacturer, and intended use.
04
Describe the device in detail including specifications and materials used.
05
Include a summary of safety and effectiveness data.
06
Provide a comparison with predicate devices.
07
Ensure you include the necessary labeling information.
08
Review your summary for completeness and accuracy.
09
Submit the completed 510(k) SUMMARY K090845 to the FDA.
Who needs 510(k) SUMMARY K090845?
01
Manufacturers of medical devices who intend to market a device that is substantially equivalent to an existing device.
02
Companies looking to obtain FDA clearance for a new medical device.
03
Businesses engaged in the development of devices in the same category as K090845.
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How to check if a device is FDA approved?
Welcome to FDA Verification Portal This online portal provides a comprehensive list of Establishments and Health Products with License to Operate (LTO) and Certificate of Product Registration/Notification (CPR/NN) respectively. This is consumer's access to safe and quality commodities in the market.
How to look up a 510k?
Users can search the FDA 510(k) database by entering the name of a specific medical device, the name of the applicant who filed the 510(k) premarket notification paperwork for the device, or by entering the specific 510(k) number or product code associated with a given device.
How to look up 510k?
Users can search the FDA 510(k) database by entering the name of a specific medical device, the name of the applicant who filed the 510(k) premarket notification paperwork for the device, or by entering the specific 510(k) number or product code associated with a given device.
What is a 510k summary?
510(k) Summary or Statement. Prepare either a 510(k) Summary or a 510(k) Statement. The Summary or Statement is required for all 510(k)s whether the device is Class I, II, or III. A 510(k) Summary is a summary of information upon which you based your claim of substantial equivalence.
What is the rejection rate for 510k?
The FDA 510(k) submission process is a critical gateway for medical device manufacturers seeking approval for their products in the United States. However, a concerning trend has emerged – a staggering 25% of these submissions are facing rejection due to lack of completeness.
How to check if a product is registered in FDA?
Search our databases: Drugs@FDA. Find information about most FDA-approved prescription, generic, and over-the-counter drug products. Drug Shortages. Find information about drug shortages caused by manufacturing and quality problems, delays, and discontinuations. National Drug Code Directory Search. Orange Book.
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What is 510(k) SUMMARY K090845?
510(k) SUMMARY K090845 is a premarket notification submitted to the FDA to demonstrate that a medical device is safe and effective by comparison to a legally marketed device.
Who is required to file 510(k) SUMMARY K090845?
Manufacturers of medical devices that intend to market a new device that is substantially equivalent to an existing legally marketed device are required to file a 510(k) SUMMARY.
How to fill out 510(k) SUMMARY K090845?
To fill out 510(k) SUMMARY K090845, manufacturers must provide device identification, intended use, description of the device, comparison to predicate devices, and any data supporting the device's safety and effectiveness.
What is the purpose of 510(k) SUMMARY K090845?
The purpose of 510(k) SUMMARY K090845 is to inform the FDA of the device's characteristics, ensure that it meets the required standards for safety and effectiveness, and obtain clearance for market entry.
What information must be reported on 510(k) SUMMARY K090845?
Information required includes the device's name, description, intended use, labeling, and comparisons with predicate devices, as well as data from studies or tests that demonstrate safety and effectiveness.
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