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

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

Product Description

lMultiple shape of ballon isavailable.

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

lDifferent 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.

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

lStandard four-wing pleating processensures excellent passability after repeated inflation.

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

lThis 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.

COMPANY INTRODUCTIONAs 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
state-of-the-art physical-chemical testing center, providing unwavering assurance to our valued clients
three pivotal critical areas:
raw material procurement control ,
product quality control and
new product performance analysis .

CONGRESS SHOWOur world-class products are exported to numerous countries, including Columbia, France, Turkey, Indonesia, Mexico, Russia, and Thailand, amongst others. According to their feedback, the exceptional quality of our products consistently meets the rigorous standards in their countries.

OEMWaston also stands as a leading OEM supplier to some of the largest and most influential global players in this industry.

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 options are also available for our balloons, including peanut type, cylindrical type, one-side prior dilation type, unilateral type, etc.

 

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