Grai Orthopedic Implants Grai Orthopedic Implants

Pkp, Titanium Alloy, Orthopedic Implant, Spine, Surgical, Medical Instrument Set, with CE/ISO/FDA, Dislocation, Fracture, Lumber and Cervical Verterbra, Minimal

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 shapes of balloons are available for clinical flexibility.
The Kyphoplasty Balloon Catheter is specifically designed for correcting compression fractures and restoring vertebral body height.
Various sheath outer diameters (OD) and balloon shapes adapt to different thoracic and lumbar vertebral fractures, ensuring accurate dilation.
Advanced balloon materials provide excellent supportiveness, biocompatibility, biological persistence, and environmental stress cracking resistance.
A standard four-wing pleating process ensures superior passability even after repeated inflation cycles.
Rigid quality control: Each balloon undergoes pressure and seal testing to minimize risk of burst or leakage.
Primary application: Percutaneous Kyphoplasty (PKP) operations to stabilize vertebral bodies using bone cement injection.

Technical Specifications

MODEL MARKER DISTANCE CHANNEL ID OVERALL LENGTH MAX 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

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

Innovation & Manufacturing

As a national high-tech enterprise, R&D investment consistently exceeds 8% of total sales. Several innovative products have secured national invention patents, including the Rev Drill system, Three-Row-Stapler, Sternal Fixation, and Rib plate.

Medical Device Production

Operations follow strict ISO13485 quality systems and CE MDD 93/42/EEC directives. The facility utilizes German, American, and Japanese imported machining centers and automatic lathes to ensure first-class quality. The Testing Center includes a biomechanical laboratory and a physical-chemical testing center for comprehensive quality control.

Quality Testing Center

Global Congress & OEM

Products are exported globally to countries such as Columbia, France, Turkey, Indonesia, Mexico, Russia, and Thailand. High standards and quality are recognized through international feedback and major OEM partnerships with global medical players.

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Frequently Asked Questions

Q1: What is the primary use of the Kyphoplasty Balloon Catheter?
It is mainly 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 height.
Q2: What types of balloon shapes are available?
Standard shapes include Peanut and Cylindrical types. Customizations like one-side prior dilation or unilateral types are also available.
Q3: How is the quality of the balloons ensured?
Every balloon passes a rigorous pressure and seal test before leaving the factory. Manufacturing is done using high-precision equipment from Germany, the USA, and Japan.
Q4: Does the product meet international medical standards?
Yes, the manufacturing process complies with ISO13485 quality systems and the CE MDD 93/42/EEC directive.
Q5: What is the maximum pressure rating for these catheters?
The Kyphoplasty Balloon Catheters feature a PSI rating of 400PSI to ensure safety and effectiveness during dilation.
Q6: Are the materials used biocompatible?
Yes, the materials are selected for their excellent biocompatibility, biological persistence, and resistance to environmental stress cracking.

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