DGIMED Receives FDA Clearance On IM Nail System

Main Category: Bones / Orthopaedics
Also Included In: Regulatory Affairs / Drug Approvals;  Medical Devices / Diagnostics
Article Date: 24 Nov 2009 - 17:00 PST

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DGIMED ORTHO, Inc. announced 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.

Source
DGIMED ORTHO, Inc.