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Ascendx systems receive CE marking approval

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Ascendx Spine announced that the company has received ISO 13485 Certification and CE marking approval for its Ascendx VCF Repair System and its Ascendx Acu-Cut Vertebral Augmentation System to treat vertebral compression fractures.

“The Ascendx VCF Repair System and the Ascendx Acu-Cut Augmentation System are designed for the treatment of spinal fractures by spine surgeons and interventional radiologists,” Julian M. Mackenzie, chief executive officer of Ascendx Spine, stated in a company press release.

Mackenzie added in the release that Ascendx also has a 510(k) submission pending FDA clearance for its Ascendx VCF Repair System in 2011.