Aesculap's Odontoid Fracture Fixation System Receives FDA 510(k) Approval 

Center Valley, PA (January 27, 2015) – Aesculap Implant Systems announced today that it has received U.S. FDA 510(k) clearance for the Aesculap Odontoid Fracture Fixation System. The system is intended for fracture fixation of small bones and small bone fragments including odontoid fractures.

Ira Benson, Aesculap Implant Systems Vice President of Spine Marketing, commented, "We are really excited about what the Odontoid Fracture Fixation System brings to our product portfolio as it gives us an easy-to-use screw system to treat type II Odontoid fractures.”

The Aesculap Implant Systems Odontoid Fracture Fixation System was designed in collaboration with  Dr. Ron Apfelbaum, Emeritus Professor of Neurosurgery at the University of Utah Health Sciences Center.  The system is comprised of screws and instruments. The 4.0mm cortical screws are either fully-threaded or partially threaded. They are offered in various lengths and are non-sterile. The screws are manufactured from titanium alloy (Ti6Al4V) per ISO 5832/3.

For more information about Aesculap Implant Systems visit: aesculapimplantsystems.com.

Contact: 
Amy Burkey
Project Manager, Corporate Communications
Aesculap Implant Systems, LLC
1-800-234-9179
amy.burkey@aesculapusa.com

 
 

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