Alur Orthopedic Implants Alur Orthopedic Implants

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

Customization: Available
Type: Medical
Application: Orthopedic

Product Description

Basic Specifications
Material
Plastic
Feature
Disposable
Group
Adult
Specification
CE, SGS
HS Code
902110000
Product Description
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Multiple shapes of balloons are available to accommodate various anatomical needs.
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The Kyphoplasty Balloon Catheter is specifically designed for correcting compression fractures and restoring vertebral body height.
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Various sheath outer diameters (OD) are compatible with different working channels to ensure accurate dilation across thoracic and lumbar vertebrae.
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Materials feature excellent biocompatibility, biological persistence, and environmental stress cracking resistance.
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Standard four-wing pleating process ensures superior passability, even after repeated inflation cycles.
Rigid quality control: Each unit undergoes pressure and seal testing to minimize the risk of burst or leakage.
Spine Surgical Instrument Set
Manufacturing Excellence

Quality Management System: Operations adhere strictly to ISO13485, medical device manufacturing specifications, and the CE MDD 93/42/EEC directive.

Advanced Equipment: Utilizing German and American-imported machining centers alongside Japanese-imported automatic lathes to ensure precision and first-class quality.

Testing Capabilities: Our expansive testing center includes a biomechanical laboratory and a state-of-the-art physical-chemical testing center for raw material control and product performance analysis.

Manufacture Process
International Presence

Our medical devices are exported globally to countries including Columbia, France, Turkey, Indonesia, Mexico, Russia, and Thailand, consistently meeting 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 400 PSI Peanut Type
KBO120 20 ≥3.6 315 6cc 400 PSI Cylindrical Type
KBO210 10 ≥3.6 315 3cc 400 PSI Cylindrical Type

Note: Customization options available for peanut type, cylindrical type, one-side prior dilation type, and unilateral type.

Frequently Asked Questions
What is the primary application of this balloon catheter?
It is primarily used in Percutaneous Kyphoplasty (PKP) operations to dilate the vertebral body and create a cavity for bone cement injection.
What balloon shapes are available for different fractures?
We offer multiple shapes including Peanut type, Cylindrical type, and unilateral dilation types to adapt to various thoracic and lumbar vertebral fractures.
Are the devices reusable or disposable?
These balloon catheters are designed as disposable (single-use) medical devices to ensure patient safety and maintain sterile standards.
What certifications do your orthopedic products hold?
Our products are manufactured under ISO13485 quality systems and hold CE and SGS certifications, meeting international medical standards.
How do you ensure the safety and burst resistance of the balloons?
Each balloon undergoes rigorous pressure and seal testing at 400 PSI before leaving the factory to minimize risks of leakage or bursting during surgical procedures.
Do you offer OEM manufacturing services?
Yes, we serve as a leading OEM supplier for several major global players in the medical device industry, utilizing advanced imported machinery.

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