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

• Multiple shape of balloon is available.
• Kyphoplasty Balloon Catheter is designed for correcting compression fractures and restoring vertebral body height. Appropriate balloons are selected for dilation according to fracture types.
• Different OD of the sheath can be applied to different working channels to realize accurate dilation. Different shapes adapt to thoracic vertebrae, lumbar vertebrae, and other fracture types.
• Balloon materials feature excellent supportiveness, biocompatibility, biological persistence, surface anti-biodegradation, and environmental stress cracking resistance.
• Standard four-wing pleating process ensures excellent passability after repeated inflation.
• Each balloon passes strict pressure and seal tests to minimize risk of burst and leakage.
• Mainly used in Percutaneous Kyphoplasty (PKP) operations to dilate the vertebral body and form a cavity for bone cement injection.

"Good faith as the base, quality above all" is the core philosophy. Operations adhere strictly to the ISO13485 quality system, medical device manufacturing specifications, and the CE MDD 93/42/EEC directive.

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

World-class products are exported to numerous countries including Columbia, France, Turkey, Indonesia, Mexico, Russia, and Thailand. Feedback consistently confirms that product quality meets rigorous international standards.

We also serve as a leading OEM supplier to major global players in the medical industry.

Customization options include peanut type, cylindrical type, one-side prior dilation type, unilateral type, and more.