The FDA just cleared Orthopedic Designs North America, Inc.'s humeral nail in under 30 days. The agency received the clearance request on January 26, 2018 and notified the company on February 22, 2018.
According to the FDA filings, “the Talon DistalFix Humeral Nail system is indicated to aid in the alignment and stabilization of humeral fractures, including:
The company says the device eliminates the need for freehand drilling and distal locking screws, resulting in less operative time, elimination of stress risers, fewer incisions, reduced radiation exposure and decreased operating room expenses.
The system, according to FDA documents, consists of the following parts:
The predicate device for comparison was the Synthes Titanium Cannulated Humeral Nail Expert System.
Dear I want to know which company manufacturer this product ? Is this product suitable for femur shaft comminuted fracture?
Your email address will not be published. Required fields are marked *
Email Address (will not be published) *
Save my name, email, and website in this browser for the next time I comment.
This site uses Akismet to reduce spam. Learn how your comment data is processed.
Copyright © 2020 RRY Publications, LLC. All Rights Reserved. Sitemap. Privacy Policy