DGIMED Ortho, Inc. Receives FDA Clearance on IM Nail System
11/23/2009 10:49:12 AM
MINNETONKA, Minn.--(BUSINESS WIRE)--DGIMED ORTHO, Inc. announced today that the company has received notification of clearance on its 510(k) submission for the Company’s proprietary Drill and Intramedullary (IM) Nail system.
“This timely notification keeps us on track as we now plan to initiate our market validation work to gain additional feedback on our system. This will significantly contribute to our continued development of the next generation DISTALOCK Drill and IM Nail system.” said Phil Smith, the Company’s President and CEO. “This is great news!”
The Drill System uses an innovative approach to ensure the accurate placement of the distal locking screws used to stabilize the rod-like implants used for long bone fractures of the femur and tibia. The proprietary system is designed to improve clinical outcomes by facilitating faster and more accurate placement of distal locking screws while reducing the amount of x-ray required with most placement techniques. As a result, procedure time should be significantly reduced, lowering surgery facility and staff costs and reducing radiation exposure for the orthopedic surgeon, hospital staff, and the patient.
DGIMED ORTHO, Inc. is a start-up medical device company that specializes in a new, proprietary system to assist orthopedic surgeons in the delivery and distal locking of long bone intramedullary nail implants. The Company is located at 12400 Whitewater Drive, Suite 2010, Minnetonka, MN 55343. www.dgimedortho.com.