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FBC Device receives CE mark, ISO certification for spinal implant

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FBC Device has received CE mark and ISO certification for its Statur-L spinal fusion implant, with plans to launch the device in the European and Canadian markets.

Statur-L is a hybrid of fusion and non-fusion technology. According to a company press release, surgeons gain a better way to address the loss of spinal curvature common in patients undergoing fusion. Additionally, the design reduces the number of implants needed during surgery.

"We are pleased to have achieved both ISO 13485 and CE mark. We are committed to produce innovative and high quality spinal implants supported by significant experimental and clinical documentation," Finn Bjarke Christensen, founder and chief executive officer of FBC Device, stated in the release.