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This document serves as a 510(k) summary for the DePuy Mitek Milagro Interference Screws, detailing their classification, design specifications, and substantial equivalence to predicate devices, as

How to fill out milagro interference screws 510k

How to fill out Milagro Interference Screws 510(k) Summary

1. Gather all necessary product information, including device description and intended use.
2. Collect data on safety and effectiveness, including clinical data if available.
3. Prepare labeling information, including indications for use and instructions for use.
4. Complete the 510(k) form including all required sections such as device description, predicate devices, and comparison information.
5. Compile performance testing data results to demonstrate equivalence to a legally marketed device.
6. Review the summary for clarity, accuracy, and compliance with FDA requirements.
7. Submit the completed 510(k) Summary electronically according to FDA guidelines.

Who needs Milagro Interference Screws 510(k) Summary?

1. Manufacturers of Milagro Interference Screws seeking FDA clearance.
2. Healthcare providers interested in using Milagro Interference Screws for their patients.
3. Regulatory professionals involved in medical device approval processes.

People Also Ask about

What are the complications of bioabsorbable screws?

Reported complications for bioabsorbable screws include screw breakage, inflammatory or foreign body reaction, tunnel , and delayed graft healing/integration.

What is the Section 510 K of the Federal Food Drug and Cosmetic Act?

A 510(k) is a premarket submission made to FDA to demonstrate that the device to be marketed is as safe and effective, that is, substantially equivalent, to a legally marketed device (section 513(i)(1)(A) FD&C Act).

Which screw is better for ACL surgery?

It is possible to fix the ACL with both bone-to-bone and soft tissue-to-bone PEEK interference screws. These screws are strong and flexible, which helps the healing process.

What is the FDA 510k summary?

Overview of Section 510(k) This allows FDA to determine whether the device is equivalent to a device already placed into one of the three classification categories. Thus, "new" devices (not in commercial distribution prior to May 28, 1976) that have not been classified can be properly identified.

What is a Milagro screw?

DESCRIPTION. MILAGRO Advance Interference Screw is designed to offer exceptional bite, rapid insertion and excellent fixation strength. The proprietary biocomposite material, BIOCRYL RAPIDE™, has human clinical data demonstrating full absorption over time.

What is the material of Milagro screw?

MILAGRO Advance Interference Screw is designed to offer exceptional bite, rapid insertion and excellent fixation strength. The proprietary biocomposite material, BIOCRYL RAPIDE™, has human clinical data demonstrating full absorption over time.

What is a clamp screw used for?

A screw clamp is a tool designed to join or hold two or more objects firmly together. It uses a screw mechanism to adjust its jaws and clamp a workpiece in place. It is useful when holding or gluing components, for example, wood, paper, plastic, or various metals.

For pdfFiller’s FAQs

What is Milagro Interference Screws 510(k) Summary?

The Milagro Interference Screws 510(k) Summary is a document submitted to the FDA that demonstrates the safety and effectiveness of a medical device, specifically the Milagro Interference Screws, by providing evidence that it is substantially equivalent to an already legally marketed device.

Who is required to file Milagro Interference Screws 510(k) Summary?

Manufacturers or sponsors of the Milagro Interference Screws seeking market approval in the United States are required to file the 510(k) Summary.

How to fill out Milagro Interference Screws 510(k) Summary?

To fill out the Milagro Interference Screws 510(k) Summary, manufacturers must include details such as device description, intended use, predicate devices, performance data, labeling information, and any additional information requested by the FDA.

What is the purpose of Milagro Interference Screws 510(k) Summary?

The purpose of the Milagro Interference Screws 510(k) Summary is to provide the FDA with sufficient information to determine whether the device is safe and effective for its intended use, and to allow for its clearance for marketing in the U.S.

What information must be reported on Milagro Interference Screws 510(k) Summary?

The information that must be reported includes device name, classification, intended use, manufacturing information, comparison to predicate devices, performance and safety data, and labeling and promotional materials.