Orthopedic Titanium Alloy Spine Surgical Instrument Set with CE/ISO/FDA

• Multiple shapes of balloons are available to suit clinical needs.
• Kyphoplasty Balloon Catheter is specifically designed for correcting compression fractures and restoring vertebral body height. Doctors can choose the appropriate balloon for dilation based on fracture types.
• Different Outer Diameters (OD) of the sheath can be applied to various working channels to realize accurate dilation. Different shapes adapt to thoracic vertebrae, lumbar vertebrae, and other fracture types.
• The balloon materials feature excellent characteristics, including fine supportiveness, biocompatibility, biological persistence, surface anti-biodegradation, and environmental stress cracking resistance.
• Standard four-wing pleating process ensures excellent passability even after repeated inflation.
• Each balloon passes rigorous pressure and seal tests before leaving the factory. Strict quality control measures minimize the risk of balloon burst and leakage.
• This device is mainly used in Percutaneous Kyphoplasty (PKP) operations to dilate the vertebral body and form a cavity for injecting bone cement to recover and stabilize the vertebral body.

Operating strictly according to the ISO13485 quality system, our production process adheres to medical device manufacturing quality management specifications for implants and sterile devices, as well as the CE MDD 93/42/EEC directive.

The facility utilizes high-end processing equipment, including German-imported and American-imported machining centers, and Japanese-imported automatic lathes, ensuring first-class quality. The Testing Center includes a biomechanical laboratory and a state-of-the-art physical-chemical testing center, focusing on raw material procurement control, product quality control, and new product performance analysis.

Customization options are available, including peanut type, cylindrical type, one-side prior dilation type, unilateral type, etc.