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www.fdanews.com/articles/122539-company-gets-510-k-for-im-nail-system

Company Gets 510(k) for IM Nail System

November 24, 2009
DGIMed Ortho received 510(k) clearance from the FDA for its drill and intramedullary (IM) nail system, according to a company statement. The device ensures 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. It reduces procedure time, lowers costs and limits radiation exposure for patients and healthcare providers.