Blutree Orthopedic Implants Blutree Orthopedic Implants

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

Customization: Available
Type: Medical
Application: Orthopedic

Product Description

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Basic Information

Material
Plastic
Feature
Disposable
Group
Adult
Specification
CE, SGS
Origin
Changzhou, Jiangsu
HS Code
902110000
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Product Description

Multiple shapes of balloon are available to meet various clinical needs.
Kyphoplasty Balloon Catheter is specifically designed for correcting compression fractures and restoring vertebral body height. Doctors can choose the appropriate balloon dilation based on specific fracture types.
Different outer diameters (OD) of the sheath can be applied to various working channels to realize accurate dilation. Different balloon shapes adapt to thoracic vertebrae, lumbar vertebrae, and other fracture types.
Advanced balloon materials offer excellent supportiveness, biocompatibility, biological persistence, surface anti-biodegradation, and environmental stress cracking resistance.
A standard four-wing pleating process ensures excellent passability even after repeated inflation cycles.
Each balloon undergoes rigorous pressure and seal testing before leaving the facility. Strict quality control measures minimize the risk of burst and leakage.
Primary application: Percutaneous Kyphoplasty (PKP) operations to dilate the vertebral body and form a cavity for bone cement injection, aiding in the recovery and stabilization of the vertebral body.
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Manufacture & Quality Control

"Good faith as the base, quality above all" - This philosophy drives our entire production process.

Our facility operates strictly according to the ISO13485 quality system, adhering to medical device manufacturing quality management specifications for implants and sterile devices, as well as the CE MDD 93/42/EEC directive.

We utilize high-precision equipment including German and American-imported machining centers, and Japanese-imported automatic lathes. Our state-of-the-art Testing Center includes a biomechanical laboratory and a physical-chemical testing center, ensuring excellence in raw material procurement, product quality, and performance analysis.

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Global Congress & Exhibition

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

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Technical Specifications

MODEL MARKER DISTANCE (mm) CHANNEL ID OVERALL LENGTH (mm) MAX VOLUME PSI RATING BALLOON TYPE
KBO115 15 ≥3.6 315 4cc 400PSI Peanut Type
KBO120 20 ≥3.6 315 6cc 400PSI Cylindrical Type
KBO210 10 ≥3.6 315 3cc 400PSI Cylindrical Type

* Customization options are available for various balloon types including one-side prior dilation, unilateral types, and more.

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Frequently Asked Questions

What is the primary use of the Kyphoplasty Balloon Catheter?
It is primarily used in Percutaneous Kyphoplasty (PKP) operations to dilate the vertebral body, creating a cavity for bone cement injection to stabilize fractures.
What shapes are available for the balloons?
We offer multiple shapes including Peanut Type, Cylindrical Type, one-side prior dilation, and unilateral types to suit different thoracic and lumbar vertebrae requirements.
How is the quality of the balloons ensured?
Each balloon undergoes rigorous pressure and seal tests. We maintain ISO13485 certification and follow CE MDD 93/42/EEC directives using advanced imported machining centers.
What are the material characteristics?
The materials feature excellent biocompatibility, supportiveness, and resistance to environmental stress cracking and biodegradation.
Does the balloon retain its shape after repeated inflation?
Yes, the standard four-wing pleating process is designed to ensure excellent passability and structural integrity even after repeated inflation.
Can these products be customized for OEM needs?
Yes, we serve as a leading OEM supplier for several major global players in the medical device industry, offering extensive customization options.

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