Healthcare system company SIG Medical reported on Thursday the receipt of the US Food and Drug Administration's (FDA) 510(k) clearance for its enhanced AdvantageRib System, K183317, in a limited market release.
K183317 is the company's third rib fracture revolutionary alternative to a traditional rib fixation systems under the US FDA 510k.
The latest US FDA's 510k clearance features new implants to treat patients along the entire spectrum of bone quality, with modifications to existing implants to improve surgeon experience, as well as strengthens the company's position in the most comprehensive rib fracture products market.
Following the US FDA's 510k, the company plans to unveil K183317 at the 2019 Chest Wall Injury Society (CWIS) Annual Meeting, where the leading experts gather to focus on operative care of patients with chest wall injures. It plans to conduct hands on training at the meeting in Sante Fe.
AdvantageRib has reportedly been utilised in over 50 rib fractures with the first patient treated nearly two years ago, concluded the company.
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