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

• Type: Medical
• Application: Orthopedic
• Material: Plastic
• Feature: Disposable
• Group: Adult
• Specification: CE, SGS
• Trademark: Waston Medical
• Origin: Changzhou, Jiangsu
• HS Code: 902110000

Product Description

l  Multiple shape of ballon isavailable.

l Kyphoplasty Balloon Catheter is designed for correctingcompression fractures and restoring vertebral body height. Doctors shouldchoose appropriate balloon for dilation according to fracture types.

l Different OD of the sheath can beapplied to different working channel to realize accurate dilation, Differentshapes of the balloon can adapt to different thoracic vertebra, lumbar vertebraas well as other types of fractures.

l The balloon materials feature withexcellent characteristics, such as fine supportiveness, biocompatibility,blological persistence, surface anti-biodegradation and environmental stresscracking resistance.

l Standard four-wing pleating processensures excellent passability after repeated inflation.

l Each balloon has passed the pressureand seal test before leaving the factory. Strict quality control measuresminimize the risk of balloon burst and leakage.

l This device is mainly used inPercutaneous Kyphoplasty(PKP) operation to dilate vertebral body and form acavum which is for injeting bone cement to recover and stabilize vertebralbody.

 

Specifications

 

MODEL	DISANCE OF TWO  RADIOPAQUE MARKERS	CHANNEL ID	OVERALL LENGTH	MAXIMUM 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 is also acceptable to our balloons, such aspeanut type, cylindrical type, one-side prior dilation type, unilateral type,etc.

 

 

 

COMPANY INTRODUCTION

As a national high-tech enterprise, the proportion of our R&D investment to total sales has been over 8% for consecutive years, realizing the transformation of the experts' clinical experience and their innovative ideas into achievements, launched several innovative products which have the national invention patents and patents for utility model. At present, we pioneer globally the revolutionary innovation technology of Rev Drill system,Three-Row-Stapler,Sternal Fixation and Rib plate, which are fully endorsed by both the experts and the market, as a national brand and benchmarking of innovative products in the domestic medical devices industry.

MANUFACTURE INTRODUCTION

"Good faith as the base, quality above all" is Waston's Philosophy. 

Waston operates strictly according to the ISO13485 quality system, at the same time proceed the specifications of medical devices manufacturing quality management, implants and sterile medical devices execution rules, as well as the CE MDD 93/42/EEC directive implementation.  

In recent years we have formed the quality control system of international standard level by constant upgrading, standardization of management in details, improvement of the whole process control. We have also imported a lot of processing equipment, including the German-imported and American-imported machining centers, Japanese-imported automatic lathes and so on, ensuring our first-class quality by first-class equipment. Since 2011 we've invested over 20 million RMB in the expansion of our Testing Center, which is divided into a biomechanical laboratory and a physical-chemical testing center, providing powerful assurance to our three key critical points: raw material procurement control, product quality control and new product performance analysis.

CONGRESS SHOW

Our products are exported to many countries, such as Columbia, France, Turkey, Indonesia, Mexico, Russia, and Thailand etc. According to their feedbacks, the quality of our products can well meet the standards in their countries.
 

O E M

Waston is also as a major OEM supplier to some of the largest global players in this industry. 

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