Kua Whakaaetia e te FDA te Pūnaha Tīwiri Pedicle Whakauru-Mīhini

Ko te pūnaha tīwiri waewae o te thoracolumbar, te ingoa waitohu OsteoCentric Spine MIS Pedicle Fastener System, i hangaia e OsteoCentric Technologies, he "mea i hangaia hei whakapiri me te whakau i ngā wāhanga tuaiwi i roto i ngā tūroro pakeke angaiwi hei maimoatanga whakakotahi mō te koretake, te hapa rānei o te uma me te hope, te hope me te hope o te tinana".
Ina koa, ko ngā tīwiri waewae he mea hanga mō te "whakapiri waewae kore-pūtau mō ngā tohu e whai ake nei:
He rite tonu te pūnaha tīwiri waewae thoracolumbosacral ki te pūnaha tīwiri waewae thoracolumbosacral a Altus Partners, LLC.
E ai ki a OsteoCentric, ka whakamahia te hangarau UnifiMI i roto i te OsteoCentric Pedicle Screw Fastener System™. I roto i tētahi panuitanga pāpāho, i whakamārama a Eric Brown, te Kaiwhakaū me te Tumu Whakahaere Matua o OsteoCentric, "Ko te pūnaha whakapiri kakau UnifiMI anake te pūnaha kei te mākete e whakamahi ana i te hangarau whakauru miihini hei whakakore i te kore pumau o te whakatō i te hononga wheua-whakatō."
I te whakaaetanga a te FDA 510(k) mō te pūnaha tīwiri waewae, kua piki ake te kaha o OsteoCentric i roto i te mākete me te whakaaetanga a te FDA 510(k) mō tana pūnaha hononga sacroiliac me te putea tipu whakapaipai e arahina ana e OnPoint Advisors. Ka tautoko te Foundation i te whakaurunga miihini ki roto i te orthopedics me te niho.


Wā tuku: Hakihea-20-2022