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

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

Customization:	Available
Type:	Medical
Application:	Orthopedic

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Product Description

📋 Basic Info.

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.

🏢 Company Overview

As a national high-tech enterprise, the proportion of our R&D investment to total sales has been over 8% for consecutive years. We focus on transforming clinical experience into innovative solutions, launching products with national invention patents. We offer revolutionary technology including Rev Drill system, Three-Row-Stapler, Sternal Fixation, and Rib plates, which are highly endorsed by experts and the market.

🛠️ Manufacture & Quality Control

"Good faith as the base, quality above all" is our core philosophy. We operate strictly according to the ISO13485 quality system, sterile medical device execution rules, and CE MDD 93/42/EEC directives.

Our facilities include German-imported and American-imported machining centers, and Japanese-imported automatic lathes. Our Testing Center includes a biomechanical laboratory and a state-of-the-art physical-chemical testing center, ensuring control over raw material procurement, product quality, and new product performance analysis.

🌍 Global Congress & OEM

Our products are exported to numerous countries, including Columbia, France, Turkey, Indonesia, Mexico, Russia, and Thailand. We also serve as a leading OEM supplier to major global players in the medical industry.

📊 Specifications

MODEL	DISTANCE OF TWO 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		Cylindrical Type
KBO210	10	≥3.6	315	3cc		Cylindrical Type

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

❓ Frequently Asked Questions

Q1: What is the primary medical application for this balloon catheter?

A1: It is primarily used in Percutaneous Kyphoplasty (PKP) operations to dilate the vertebral body and create a cavity for bone cement injection to recover and stabilize vertebral fractures.

Q2: What types of balloon shapes are available for different fractures?

A2: We offer multiple shapes including Peanut type, Cylindrical type, one-side prior dilation type, and unilateral type to adapt to different thoracic and lumbar vertebrae fractures.

Q3: How is the quality and safety of each balloon catheter guaranteed?

A3: Every balloon undergoes strict pressure and seal tests before leaving the factory. Our four-wing pleating process and high-grade materials minimize the risk of burst or leakage.

Q4: What are the key material characteristics of the balloon?

A4: The materials provide excellent supportiveness, biocompatibility, biological persistence, and resistance to environmental stress cracking and biodegradation.

Q5: Which international quality standards do your manufacturing processes meet?

A5: Our manufacturing strictly follows ISO13485 quality systems and CE MDD 93/42/EEC directives to ensure global medical standard compliance.

Q6: What is the maximum pressure rating for these catheters?

A6: The standard specifications for the listed models provide a pressure rating of 400 PSI.

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

Product Description

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