Hukumar FDA Ta Amince Da Tsarin Sukurin Feda Mai Haɗaka Da Inji

Tsarin sukurori na ƙafar thoracolumbar, wanda aka yi wa lakabi da OsteoCentric Spine MIS Pedicle Fastener System, wanda OsteoCentric Technologies kera, ba shakka, "an yi shi ne don gyarawa da daidaita sassan kashin baya a cikin marasa lafiya da suka manyanta a matsayin magani mai haɗaka ga rashin kwanciyar hankali ko nakasar da ke da tsanani da kuma nakasar ƙwanƙoli, ƙashin baya da na kullum".
Musamman, an yi nufin sukurori na pedicle don "gyaran pedicle mara mahaifa don waɗannan alamu:
Tsarin sukurin pedicle na thoracolumbosacral iri ɗaya ne da tsarin sukurin pedicle na Altus Partners, LLC.
A cewar OsteoCentric, Tsarin OsteoCentric Pedicle Screw Fastener System™ zai ƙunshi fasahar UnifiMI. A cikin wata sanarwa da ya fitar, Eric Brown, wanda ya kafa kuma shugaban kamfanin OsteoCentric, ya bayyana cewa, "Tsarin haɗe-haɗen tushe na UnifiMI zai zama tsarin da kawai ke kasuwa wanda ke amfani da fasahar haɗakar injina don kawar da rashin daidaiton dashen a mahaɗin ƙashi da dashen."
Tare da amincewar FDA 510(k) don tsarin sukurori na ƙafa, OsteoCentric ya sami ƙarin ci gaba a kasuwa tare da amincewar FDA 510(k) don tsarin haɗin gwiwa na sacroiliac da asusun haɓaka jari wanda OnPoint Advisors ke jagoranta. Gidauniyar za ta tallafawa haɗakar injina a fannin kashin baya da haƙori.


Lokacin Saƙo: Disamba-20-2022