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

• Multiple shapes of balloon are available to meet various clinical needs.
• Kyphoplasty Balloon Catheter is specifically designed for correcting compression fractures and restoring vertebral body height.
• Different outer diameters (OD) of the sheath can be applied to various working channels for accurate dilation.
• Advanced balloon materials provide excellent supportiveness, biocompatibility, biological persistence, and environmental stress cracking resistance.
• Standard four-wing pleating process ensures superior passability even after repeated inflation.
• Strict quality control: Each balloon undergoes rigorous pressure and seal testing to minimize the risk of burst or leakage.
• Primary Application: Used in Percutaneous Kyphoplasty (PKP) operations to dilate the vertebral body and create a cavity for bone cement injection.

Our production facilities operate strictly under ISO13485 quality systems and CE MDD 93/42/EEC directives. We utilize world-class equipment, including machining centers imported from Germany and the USA, and automatic lathes from Japan, ensuring top-tier precision and quality.

Our testing center includes a biomechanical laboratory and a physical-chemical testing center, focusing on three critical areas: raw material procurement control, product quality control, and new product performance analysis.

Additional customization options: peanut type, cylindrical type, one-side prior dilation type, unilateral type, and more.

Our products are exported to numerous countries including France, Turkey, Indonesia, Mexico, Russia, Columbia, and Thailand. We also serve as an OEM supplier for major global players in the medical industry.