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aap Implantate receives 510k clearance for small fragment plating line
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aap Implantate AG announced that it has received 510k clearance from the FDA for the small fragment plating line of its Loqteq product family.
According to a press release, Loqteq is an anatomic, angle-stable orthopedic trauma plating system that enables lock and compression with a single hole an provides surgeons with variable compression from 0 mm to 2 mm. Consisting of a straight plate, a reconstruction plate, a one-third tubular plate and cortical screws, the small fragment system is one of six clearances anticipated for the Loqteq portfolio.
“This first 510k clearance for the Loqteq system marks a major milestone in international marketing of aap’s Loqteq trauma portfolio and another step forward in our strategy to focus on our core business and expand outside of Europe,” Biense Visser, chief executive officer of aap Implantate AG, stated. “We anticipate that the rest of the Loqteq product family will subsequently receive FDA clearance, providing a substantial enhancement of aap’s trauma portfolio in the United States. We are currently evaluating potential marketing partners and distribution opportunities for Loqteq in the United States and believe it will be successful based on its innovative features.”