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aap Implantate AG Receives Initial FDA 510(k) Clearance for its LOQTEQ Trauma Plating System
Small Fragment Plating Line is First in New LOQTEQ Product Family to Receive FDA Clearance
Biense Visser, Chief Executive Officer of aap Implantate AG, said, "This first 510(k) 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. The LOQTEQ® system was developed from proprietary locking-compression technology, which is already patented and used in Europe. 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 U.S. We are currently evaluating potential marketing partners and distribution opportunities for LOQTEQ® in the U.S. and believe it will be successful based on its innovative features."
The 510(k) cleared small fragment LOQTEQ® system consists of a straight plate, a reconstruction plate, a one-third tubular plate and LOQTEQ® cortical screws. This 510(k) clearance is one of six clearances anticipated for the LOQTEQ® portfolio, with the remaining expected to be granted in the coming weeks.
At present, six LOQTEQ® systems (small and large fragments, humerus, femur, proximal lateral and distal medial tibia) are marketed internationally in the CE region. The worldwide launch of an additional eight LOQTEQ® systems that are currently under development is planned for financial year 2013.
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