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

Customization: Available
Type: Medical
Application: Orthopedic

Product Description

Basic Information
Material: Plastic
Feature: Disposable
Group: Adult
Specification: CE, SGS
HS Code: 902110000
Product Description
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.
Innovation & R&D

As a national high-tech enterprise, the proportion of our R&D investment to total sales has been over 8% for consecutive years, realizing the transformation of the experts' clinical experience and their innovative ideas into achievements, launched several innovative products which have the national invention patents and patents for utility model. At present, we pioneer globally the revolutionary innovation technology of Rev Drill system, Three-Row-Stapler, Sternal Fixation and Rib plate, which are fully endorsed by both the experts and the market.

Orthopedic Surgical Instrument Set
Manufacturing Excellence
"Good faith as the base, quality above all"

Our operation follows strictly according to the ISO13485 quality system, medical devices manufacturing quality management, implants and sterile medical devices execution rules, as well as the CE MDD 93/42/EEC directive implementation.

We have imported advanced processing equipment, including German-imported and American-imported machining centers, Japanese-imported automatic lathes, ensuring first-class quality. Our Testing Center includes a biomechanical laboratory and a state-of-the-art physical-chemical testing center, focusing on raw material procurement control, product quality control, and new product performance analysis.

Manufacturing Center
Global Presence & OEM

Our world-class products are exported to numerous countries, including Columbia, France, Turkey, Indonesia, Mexico, Russia, and Thailand. We also stand as a leading OEM supplier to some of the largest global players in the medical industry.

Specifications
MODEL DISTANCE OF TWO RADIOPAQUE MARKERS CHANNEL ID OVERALL LENGTH MAXIMUM VOLUME PSI RATING BALLOON TYPE
KBO115 15 ≥3.6 315 4cc 400PSI Peanut Type
KBO120 20 ≥3.6 315 6cc Cylindrical Type
KBO210 10 ≥3.6 315 3cc Cylindrical Type

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

Frequently Asked Questions
What is the main application of the Kyphoplasty Balloon Catheter?
The device is primarily used in Percutaneous Kyphoplasty (PKP) operations to dilate the vertebral body and create a cavity for bone cement injection, which helps recover and stabilize the vertebral body after compression fractures.
What balloon shapes are available for selection?
We offer various shapes including Peanut type and Cylindrical type. Customization options like one-side prior dilation and unilateral types are also available to adapt to different thoracic and lumbar vertebrae fractures.
How do you ensure the safety and quality of the balloons?
Each balloon undergoes strict pressure and seal testing before leaving the factory. Our manufacturing process follows ISO13485 and CE standards to minimize the risk of burst or leakage during procedures.
What are the material characteristics of the catheter?
The catheter is made from high-performance materials featuring excellent biocompatibility, biological persistence, surface anti-biodegradation, and resistance to environmental stress cracking.
Does the balloon retain its passability after repeated inflation?
Yes, we utilize a standard four-wing pleating process that ensures the balloon maintains excellent passability even after repeated inflation cycles during the operation.
What certifications do your orthopedic products hold?
Our products are manufactured under strict quality control systems and hold international certifications including CE (MDD 93/42/EEC), ISO13485, and SGS.

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