Thursday, February 27, 2014

News - EDGE™ Orthopaedics Receives First FDA 510(k) Clearance for BITE™ Compression Screws


EDGE™ Orthopaedics, a new entry into the orthopedic medical device space, is excited to announce they have received their first FDA 510(k) clearance for BITE™ Compression Screws. Established in mid-2012, the company has embarked on building a robust quality system and developing a platform of products that once on the market could make an immediate impact.
According to Dr. Stephen Brigido, President and CSO of EDGE Orthopaedics, "compression screws are used in approximately 90% of foot and ankle procedures and are the backbone of every orthopedic extremity company.  With a comprehensive range of sizes in both headed and headless options – not to mention an extremely low profile head and better "BITE" – EDGE is building a strong foundation for future growth."
With the first cases under their belt and a pipeline of products in development, EDGE Orthopaedics is embarking on a limited launch Q2. A full launch is expected in the second half of 2014 as they receive additional 510(k) clearances.
About EDGE Orthopaedics
EDGE Orthopaedics is a privately held medical device company developing products and solutions for extremity orthopedics. Aiming to always be on the leading-edge of healthcare, the company will partner with surgeons and healthcare facilities to streamline products, processes and vendor management. With a hybrid approach to surgical solutions and distribution, EDGE Orthopaedics strives to continuously improve quality, efficiency, and add value. 
Published at - PR News Wire

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