In recent news, Neo Medical’s Pedicle Screw System has received approval from the US Food and Drug Administration (FDA) 510(k) clearance for the use of its pedicle screw system in late-stage tumour indications. Additionally, the company obtained CE certification for its 8mm screws, iliac screws and connectors, as well as rod-to-rod connectors. This is a significant milestone for Neo Medical as it provides more options to physicians and patients.
The approval from the FDA and CE certification confirms that the Neo Medical Pedicle Screw System is safe and effective for use in the management of late-stage tumour indications. This is a significant achievement for the company and demonstrates their commitment to providing innovative solutions to the medical community and their patients.
The Pedicle Screw System consists of screws, rods and connectors that are used to stabilise the spine in spinal fusion procedures. The system is designed to provide optimal fixation for the spine while reducing the risk of complications. The system is made of high-quality materials and is intended to be used in conjunction with cement to provide additional stability.
One of the unique features of the Neo Medical Pedicle Screw System is that it can be used in combination with BonOs Inject Cement from OSARTIS. This cement is specifically designed for use in spinal applications and provides an added layer of support and stabilisation. With the combination of the Neo Medical Pedicle Screw System and the BonOs Inject cement, physicians now have a reliable and safe option for the management of late-stage tumour indications.
The CE certification for the Neo Medical Pedicle Screw System is equally significant. This certification ensures that the product meets the standards of the European Union and can be sold throughout Europe. This is important for patients and physicians alike as it provides access to a reliable and safe product.
In conclusion, the Neo Medical Pedicle Screw System is an excellent example of innovative medical products that offer solutions to physicians and patients. The approval of the system by the FDA and the CE certification provides more options for late-stage tumour indications, which can significantly impact patient outcomes. The use of the BonOs Inject cement in combination with the Neo Medical Pedicle Screw System offers even more stability and support to spinal fusion patients. With the addition of the 8mm screws, iliac screws and connectors, as well as rod-to-rod connectors, the Neo Medical Pedicle Screw System offers a complete solution for spinal fusion procedures. Finally, ground ball screws are widely used in various industries like aerospace, military, energy, and medical systems. These screws are capable of handling high loads, high precision, and are known for their high reliability. The new certification from Neo Medical will create a direct impact on the ground ball screws market, increasing its importance in the orthopedics industry.