SpineCraft Receives 510(k) Clearance for ASTRA Fenestrated Screws ASTRA 6.2mm Titanium, and Cobalt Chrome Components, Strengthening Astra Spine System’s Versatility in Deformity and Degenerative Surgeries
Westmont, October 24, 2022 – SpineCraft, a leading innovator in spine surgery solutions, is proud to announce the receipt of 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its ASTRA fenestrated screws, as well as its ASTRA 6.2mm Titanium and Cobalt Chrome Rods. This significant milestone further solidifies the Astra Spine System as one of the most versatile and comprehensive systems available in the market for deformity and degenerative surgeries.
The 510(k)-clearance granted by the FDA underscores SpineCraft’s commitment to delivering cutting-edge solutions for spinal healthcare professionals and their patients. The inclusion of ASTRA fenestrated screws and the 6.2mm Titanium and Cobalt Chrome rods enhances the Astra Spine System’s capabilities, making it an indispensable choice for surgeons seeking advanced options in the treatment of deformity and degenerative spinal conditions.
“Our team at SpineCraft is thrilled to receive FDA clearance for these essential components of the Astra Spine System,” said Wagdy, CEO at SpineCraft. “This achievement reflects our dedication to providing healthcare professionals with state-of-the-art tools that enable them to achieve the best outcomes for their patients. The enhanced versatility of the Astra Spine System will undoubtedly contribute to improved patient care and treatment options.”
The ASTRA fenestrated screws offer precise and secure fixation, catering to the unique requirements of spinal deformity and degenerative surgeries. These screws are designed to provide stability and support, ensuring the long-term success of spinal procedures.
The addition of the ASTRA 6.2mm Titanium and Cobalt Chrome rods further broadens the system’s range of applications. Surgeons can now take advantage of a comprehensive set of instruments and implants designed to meet the diverse needs of their patients, facilitating more effective and personalized treatment plans.
SpineCraft is committed to continuing its tradition of innovation and excellence in the field of spinal surgery solutions. With the 510(k) clearance for ASTRA fenestrated screws and the ASTRA 6.2mm Titanium and Cobalt Chrome components, the Astra Spine System is poised to make a significant impact on the advancement of spinal healthcare.