Synicem APV System

Trade name

Synicem APV System

03700448201270

B-03700448201270

Reference / catalog number

880464

GS1

Class IIa

Applicable legislation

MDD [Directive 93/42/EEC on medical devices]

Status

On the market

Quantity

1

Additional product description

The complete cement application system for vertebroplasty is used for the application of any cement specifically designed for vertebroplasty.

Additional information URL

https://www.synimed.com/

Clinical sizes

• Ø3.0 x 150mm

European Medical Device Nomenclature — the EU product classification assigned to this device.

• A019011INTRAOSSEOUS INFUSION AND VERTEBROPLASTY INFUSION NEEDLES AND KITS

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• The Percutaneous vertebroplasty must be performed by Medical Professionals with an appropriate expertise in the method, in an institutional environment with the equipment required to ensure the normal development of the procedure and the access to an immediate treatment in case of any undesired reaction in the patient. The percutaneous vertebroplasty must be performed under real time radioscopic monitoring in order to control the cement distribution inside the vertebral body. The lack of adequate control can entail serious and even irreversible lesions in the patient. (fractures, migration of bone fragments, cement leakage into vascular, neurologic, and other structures). It is recommended that the surgeon should wear eye protection due to the risk of splashes onto the face and eyes. Note: These instructions are not meant to define or suggest any particular surgical technique. The surgeon is responsible for the choice of the appropriate procedure relative to the use of this sanitary product.

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