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

• Multiple shapes of balloons are available to suit clinical needs.
• The Kyphoplasty Balloon Catheter is 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.
• Balloon shapes adapt to different thoracic and lumbar vertebrae as well as other fracture types.
• 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 passes rigorous pressure and seal tests to minimize the risk of burst or leakage.
• Mainly used in Percutaneous Kyphoplasty (PKP) operations to dilate the vertebral body and form a cavity for bone cement injection.

Operations strictly follow the ISO13485 quality system and CE MDD 93/42/EEC directives. With continuous investment in R&D (over 8% of sales), several innovative products with national patents have been launched, including Rev Drill systems, Three-Row-Staplers, and Sternal Fixation plates.

The facility utilizes high-end equipment including German and American machining centers and Japanese automatic lathes. The Testing Center features a biomechanical laboratory and a physical-chemical testing center for raw material control and performance analysis.