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. Doctors should choose appropriate balloon for dilation according to fracture types.
• Different OD of the sheath can be applied to different working channel to realize accurate dilation. Different shapes of the balloon can adapt to different thoracic vertebra, lumbar vertebra as well as other types of fractures.
• The balloon materials feature with excellent characteristics, such as fine 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 has passed the pressure and seal test 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) operation to dilate vertebral body and form a cavum which is for injecting bone cement to recover and stabilize vertebral body.

As a national high-tech enterprise, R&D investment exceeds 8% of total sales annually. This commitment transforms clinical experience into innovative achievements, resulting in numerous national invention patents. Key revolutionary technologies include the Rev Drill system, Three-Row-Stapler, Sternal Fixation, and Rib plate systems.

Operating strictly under the ISO13485 quality system and CE MDD 93/42/EEC directives, we ensure top-tier medical device manufacturing standards. Our facility utilizes advanced German-imported and American-imported machining centers, along with Japanese-imported automatic lathes.

The state-of-the-art Testing Center includes a biomechanical laboratory and a physical-chemical testing center, ensuring rigorous control over raw material procurement, product quality, and performance analysis.

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

We serve as a leading OEM supplier to some of the largest and most influential global players in the medical device industry.

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