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

Customization: Available
Type: Medical
Application: Orthopedic

Product Description

i

Basic Information

Material:
Plastic
Feature:
Disposable
Group:
Adult
Specification:
CE, SGS
HS Code:
902110000
P

Product Description

Multiple shapes of balloon are available to suit different clinical needs.
Kyphoplasty Balloon Catheter is specifically designed for correcting compression fractures and restoring vertebral body height.
Different outer diameters (OD) of the sheath apply to various working channels for accurate dilation.
Balloon materials feature excellent characteristics, including fine supportiveness, biocompatibility, and surface anti-biodegradation.
Standard four-wing pleating process ensures excellent passability after repeated inflation.
Strict quality control: each balloon passes pressure and seal tests to minimize burst and leakage risks.
Mainly used in Percutaneous Kyphoplasty (PKP) operations to form a cavity for bone cement injection.

Innovative Technology: We utilize advanced systems including Rev Drill systems, Three-Row-Staplers, Sternal Fixation, and Rib plates, which are endorsed by industry experts globally.

M

Manufacturing Excellence

Operations follow strict ISO13485 quality systems and CE MDD 93/42/EEC directives. Our facility utilizes German-imported and American-imported machining centers along with Japanese automatic lathes to ensure first-class precision.

Our Testing Center includes a biomechanical laboratory and a state-of-the-art physical-chemical testing center for raw material procurement and product performance analysis.

G

Congress Show & Global Reach

Our world-class products are exported to numerous countries, including 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.

S

Specifications

MODEL DISTANCE OF RADIOPAQUE MARKERS 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 400PSI Cylindrical Type
KBO210 10 ≥3.6 315 3cc 400PSI Cylindrical Type

Customization options: peanut type, cylindrical type, one-side prior dilation type, unilateral type, etc.

?

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 and form a cavity for injecting bone cement to recover and stabilize the vertebrae.
What balloon shapes are available for selection?
We offer multiple shapes including Peanut type, Cylindrical type, one-side prior dilation type, and unilateral type to adapt to different thoracic and lumbar vertebral fractures.
What are the key material characteristics of the balloons?
The balloons are made from materials with excellent supportiveness, biocompatibility, biological persistence, and environmental stress cracking resistance.
How is the safety and quality of the balloons ensured?
Every balloon undergoes strict pressure and seal testing (rated at 400PSI) before leaving the factory to minimize the risk of burst or leakage.
Does the product meet international medical standards?
Yes, the manufacturing process operates strictly according to ISO13485 quality systems and complies with CE MDD 93/42/EEC directives.
What is the advantage of the four-wing pleating process?
The standard four-wing pleating process ensures the catheter maintains excellent passability even after repeated inflation during surgery.

Related Products