Aesculap’s Odontoid Fracture Fixation System Receives FDA 510(k) Approval
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
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About Aesculap Implant Systems, LLC
Aesculap Implant Systems, LLC, a B. Braun company, is part of a 175-year-old global organization focused on meeting the needs of the changing healthcare environment. Through close collaboration with its customers, Aesculap Implant Systems develops advanced spine and orthopaedic implant technologies to treat complex disorders of the spine, hip and knee. Aesculap Implant Systems strives to deliver products and services that improve the quality of patients’ lives. For more information, call 800-234-9179 or visit aesculapimplantsystems.com.