HERSHEY, Pa., Feb. 14, 2019 /PRNewswire/ -- SIG Medical announced today that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for its enhanced AdvantageRib System, K183317. This product marks the third rib fracture 510k that SIG Medical is commercializing. The latest 510k features new implants to treat patients along the entire spectrum of bone quality and modifications to existing implants to improve surgeon experience.
AdvantageRib, in a limited market release, has been utilized in over 50 rib fractures with the first patient treated nearly 2 years ago. With this 510k and the product's clinical success to date, SIG Medical plans to make AdvantageRib available nationwide next month. The US full market launch is slated to occur 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. SIG Medical has partnered with CWIS in 2019 and plans to conduct hands on training at the meeting in Sante Fe.
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About SIG Medical
SIG Medical is pioneering rib fixation optimized for the operating room. Our mission is to provide more immediate and definitive patient care: reducing pneumonia, time in intensive care, chronic pain, ventilator support, chest wall deformity, and accelerate patient recovery. We aim to improve patient care and significantly reduce the overall cost to the healthcare system.
SOURCE SIG Medical