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

• Multiple shapes of balloon are available to adapt to different thoracic and lumbar vertebrae fractures.
• Designed specifically for correcting compression fractures and restoring vertebral body height.
• Various outer diameters (OD) of the sheath can be applied to different working channels for accurate dilation.
• Materials feature excellent biocompatibility, biological persistence, surface anti-biodegradation, and environmental stress cracking resistance.
• Standard four-wing pleating process ensures excellent passability after repeated inflation.
• Each balloon undergoes rigorous pressure and seal testing to minimize the risk of burst or leakage.
• Primary use: Percutaneous Kyphoplasty (PKP) operations to dilate the vertebral body and form a cavity for bone cement injection.

Our R&D investment consistently exceeds 8% of sales, transforming clinical experience into patented medical achievements. We utilize revolutionary technologies including:

Rev Drill system, Three-Row-Stapler, Sternal Fixation, and Rib plates.

Operations adhere strictly to ISO13485 quality systems and CE MDD 93/42/EEC directives. We utilize world-class equipment to ensure precision:

• German and American-imported machining centers.
• Japanese-imported automatic lathes.
• Biomechanical laboratory and state-of-the-art physical-chemical testing center.
• Three pivotal control areas: Raw material procurement, product quality control, and new product performance analysis.

* Customization options available: one-side prior dilation type, unilateral type, etc.

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