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| Mainpage / News Archive / news2005 / Inion Receives 510(k) Clearance to Market its Biodegradable Spinal Implant Product Range in the USA |
Inion Receives 510(k) Clearance to Market its Biodegradable Spinal Implant Product Range in the USAInion S-1TM Anterior Cervical Fusion System now cleared for sale in both the USA and EU Tampere, Finland and Takeley, UK. 30th November 2005…Inion [LSE: IIN.L], a rapidly growing company focused on the development of novel biodegradable medical implants, has received FDA 510(k) clearance for the Inion S-1™ Biodegradable Anterior Cervical Fusion system for graft containment in cervical spinal fusion applications. 510(k) clearance is required of medical device manufacturers prior to commercial distribution in the US. The Inion S-1TM Cervical Fusion System, which consists of biodegradable plates and screws that, in conjunction with traditional rigid fixation, can be used to maintain the relative position of weak bony tissue such as allografts and autografts placed between vertebrae during cervical spinal fusion procedures. These procedures are carried out as a treatment for a range of spinal conditions including ruptures and displacement of inter-vertebral discs. Inion plans to develop and introduce further systems within its Spinal range over the forthcoming period. These will develop into a comprehensive suite of implants, fixation devices and instrumentation covering major spinal surgery applications. Dr Auvo Kaikkonen, CEO of Inion commented, “We are delighted to receive FDA clearance to market our S-1™ Anterior Cervical Fusion system in the USA. This is the only biodegradable product of its type that is cleared for sale in both the USA and Europe. The Spinal Market is the largest sector that Inion has targeted and this, our first product, should make a significant impact in the key world markets.” -Ends- For further information, please contact: Inion Oy Dr Auvo Kaikkonen, Chief Executive Officer Tel: +358 3 230 6600 Tim Hirst, Corporate Communications Tel: +44 (0)1279 874 222 Citigate Dewe Rogerson Mark Swallow / Helena Podd Tel: +44 (0)20 7638 9571
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