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PROCEDURAL KITS FOR KYPHOPLASTY - 7 Pages

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Catalogue excerpts

who we are G-21 was set up in 2009 by expert entrepreneurs originating from the medical and pharmaceutical sector. G-21 is situated in proximity of the main cities and infrastructures in northern Italy, approximately 40 km from Modena and Bologna, in the Italian “Medical Valley” famous all over the world for its tradition, know-how and innovative spirit in the field of Medical Devices. The company is strategically managed by a team of young people that stand out for their integrity, expertise and professionalism and who continuously bring the energy, enthusiasm and dynamism necessary to satisfy the requirements of an ever more demanding and developing market. G-21 has its own product portfolio (among which long-term implantable devices and Class III medical devices) of which it fully possesses the know-how as well as the design and production technology, the result of Research and Development programmes conducted in-house and in collaboration with major international research institutes and Universities. High-quality raw materials, absolute process control, compliance with the most stringent international standards, continuous personnel training and painstaking care to details: this is the profile of G-21's in-house production unit, which includes clean rooms certified up to Class ISO 5 for process execution in 100% sterile conditions. mission Develop innovative and more reliable solutions in the field of biomaterials and procedures for vertebral consolidation and articular functional rehabilitation, dedicated to improving therapeutic treatment of orthopaedic patients and designed to anticipate the future needs of Medical Professionals. Manufacture the products complying with the most stringent quality standards and distribute them internationally in collaboration with trade partners with whom establish and maintain long-term relationships based on trust, cooperation and responsibility. certifications Since 2010 we have been operating according to a quality system in compliance with EN ISO 13485 “Quality Management Systems - Requirements for regulatory purposes applicable to Medical Devices”. Our Quality Management System and the CE marking on our products (in accordance with Medical 93/42/EEC and subsequent amendments) are certified by the Cermet (no. 0476) and Det Norske Veritas (DNV, no. 0434) Notified Bodies, who also keep strict control to ensure that the quality levels achieved are maintained over time. Procedural kits for kyphoplasty Ky.Kit 2013-05

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PROCEDURAL KITS FOR KYPHOPLASTY Osteoporosis and metastasis may weaken the vertebrae to such to restore the height of the collapsed vertebral body bringing it a point that they fracture by effect of the compression generated back to its natural position. After removing the balloon using the by normal everyday activities, causing pain and difficult of same cannula, a specific cement is then injected into the thus created cavity in order to stabilise and consolidate the shape of the Compared to vertebroplasty, which is aimed solely at symptomatic treatment of pain, kyphoplasty also encourages The...

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KITS FOR VERTEBROPLASTY The V-KIT series for vertebroplasty includes the instruments In addition, customised kits can be made up based on specific necessary for execution of the procedure in various configura- tions, so that the operator can choose the one most suited to It is recommended to use them in combination with G-21’s bone each individual patient. cements for vertebral consolidation. TOOLS FOR KYPHOPLASTY AND BONE BIOPSY AISI 304 stainless steel needles suitable for percutaneous positioning at the same time ensuring optimal visibility of the area kyphoplasty and bone biopsy procedures. being...

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KEYFIX™ KIT FOR DIRECT ACCESS KYPHOPLASTY The V-KIT series for vertebroplasty includes the instruments It is recommended to use them in combination with G-21’s bone necessary for execution of the procedure in various configura- cements for vertebral consolidation. tions, so that the operator can choose the one most suited to each individual patient. In addition, customised kits can be made up based on specific requirements. V-KIT 03 Needle for vertebroplasty V-ACCESS™ Bone Biopsy Needle Disposable bowl and spatula 3-ml syringe with aspiration tip REF Syringe with rigid plunger - VK03 xx yyy z...

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CONTETS Needle for vertebroplasty V-ACCESS™ Biopsy needle (with 3-ml syringe and sampling tube) x 1 MiniMix™ Precision Delivery Syringe CONTETS Needle for vertebroplasty V-ACCESS™ Biopsy needle (with 3-ml syringe and sampling tube) x 1 MiniMix™ LV Bone cement closed mixing system x 1 MiniMix™ Precision Delivery Syringe REF. VK07 xx yyy z M (syringe with rigid plunger) REF. VK07 xx yyy z M (syringe with rigid plunger) REF. VK07 xx yyy z S (syringe with ergonomic handle) CONTETS Needle for vertebroplasty V-ACCESS™ Biopsy needle (with 3-ml syringe and sampling tube) x 1 PicoMix™ V (includes Mixer,...

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