FDA Yemeye Sisitemu ya Pedicle Screw Integrated Mechanical

Sisitemu yo gufunga amaguru ya thoracolumbar, izina ry’ikirango OsteoCentric Spine MIS Pedicle Fastener System, yakozwe na OsteoCentric Technologies, birumvikana ko "igamije gushimangira no gushimangira ibice by’umugongo mu barwayi bakuru b’amagufwa nk'uburyo buhuriweho bwo kuvura indwara z’imitsi cyangwa ubumuga bw’amagufwa bukabije n’ubw’igituza, ubw’umugongo n’ubw’igihe kirekire".
By’umwihariko, vis za pedicle zigenewe "gufata pedicle itari iy’umura kubera ibimenyetso bikurikira:
Sisitemu ya screw ya pedicle ya thoracolumbosacral mu by'ukuri ni imwe na sisitemu ya screw ya pedicle ya thoracolumbosacral ya Altus Partners, LLC.
Nk’uko OsteoCentric ibivuga, OsteoCentric Pedicle Screw Fastener System™ izaba ifite ikoranabuhanga rya UnifiMI. Mu itangazo ryashyizwe ahagaragara, Eric Brown, washinze akaba n'umuyobozi mukuru wa OsteoCentric, yasobanuye ati: “Uburyo bwo gufatanya inkingi za UnifiMI buzaba ari bwo buryo bwonyine ku isoko bukoresha ikoranabuhanga ryo guhuza ibyuma kugira ngo burangize kudakomera kw'ibice bishyirwa ku gice cy'amagufwa n'ibice bishyirwa ku gice cy'amagufwa.”
Nyuma yo kwemererwa na FDA 510 (k) gukoresha sisitemu yo gufunga pedicle, OsteoCentric yarushijeho gutera imbere ku isoko bitewe n’uko FDA 510 (k) yemereye sisitemu yayo yo gufunga sacroiliac hamwe n’ikigega cyo kongera imari kiyobowe na OnPoint Advisors. Iki kigo kizashyigikira ihuzwa ry’imashini mu buvuzi bw’amagufwa n’ubuvuzi bw’amenyo.