NEWS & PRESS RELEASES
Gramercy Extremity Orthopedics®, a revolutionary company transforming the Orthopedic Implant Industry, is pleased to announce the GEO® Nitinol Staple System has received FDA 510(k) clearance.
Dallas, TX — January 15th, 2018 – Gramercy Extremity Orthopedics® (GEO®) today announced it received U.S. Food and Drug Administration (FDA) 510(k) clearance for the GEO Nitinol Staple System for fixation of small bone fragments, fixation of osteotomies, and joint arthrodesis. This addition to the company’s product line marks a major milestone for Gramercy Extremity Orthopedics.
The GEO Nitinol Staple System offers a comprehensive array of sterile symmetric and asymmetric, barbed and smooth nitinol staples in various widths and lengths. Each GEO Nitinol Staple comes preloaded on individual inserters with the nitinol staple in the relaxed position. All implants and instruments within the GEO Nitinol Staple System are provided sterile. Instruments are provided in single-use kits to ensure a new and sterilized instrument is used every surgery.
“We are very pleased with the FDA clearance of the GEO Nitinol Staple System. This system will become the standard in our industry and in combination with the RFID enabled GEO CART® delivery system this will have a major impact in increasing patient safety and decreasing our customers cost”, 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 another step in that offering”.
GEO will be exhibiting at the ACFAS Scientific Conference, New Orleans, Feb 14th – 17th, 2019. Booth #301.
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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