Gramercy Extremity Orthopedics Receives FDA 510(k) Clearance for GEO™ Bone Screw System
DALLAS, Jan. 26, 2017 /PRNewswire/ — Gramercy Extremity Orthopedics (GEO) today 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.”
GEO will be exhibiting at the ACFAS Scientific Conference, Las Vegas, Feb 27th – Mar 1st, 2017. Booth #1413.
About Gramercy Extremity Orthopedics:
GEO was formed from the idea that there could exist a more cost effective, user-friendly way to supply Orthopedic Medical Implants in today’s healthcare environment. This is accomplished through the use of technology, a groundbreaking Point-of-Sale delivery system and GEO designed best in class sterilized single use orthopedic implants and instruments. GEO is the only solution that provides a significant opportunity to lower real operating costs by creating efficiencies and controls throughout the delivery and consumption of orthopedic implants.
GRAMERCY EXTREMITY ORTHOPEDICS™ and GEO™ are proprietary trademarks of Gramercy Extremity Orthopedics, LLC. All rights reserved.
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