Gramercy Extremity Orthopedics (GEO) announced it received the U.S. Food and Drug Administration’s (FDA) 510(k) clearance for the GEO™ Bone Screw System, which can be used for bone fractures, osteotomies, arthrodesis, osteochondritis, and tendon reattachments. As the first offering in the company’s product line, this marks a major milestone for Gramercy Extremity Orthopedics.
The GEO™ Bone Screw System offers a comprehensive array of low profile titanium screw lengths, diameters, thread lengths and fully threaded options. All GEO™ Bone Screws are double sterile packaged, self-drilling, self-tapping, reverse-cutting with variable length short and long threads and a hexalobe head to provide additional stability and torque transfer with less potential for head stripping. All instruments within the GEO™ Bone Screw system are also double sterile packaged in single use kits to ensure a new and sterilized instrument is used every surgery.
“We are very pleased with the clearance of the GEO™ Bone Screw System,” says Michael P. Simpson, President and CEO of Gramercy Extremity Orthopedics. “GEO is in the business of providing solutions to complex problems for our customer, and this clearance is one more step in that offering.”
