I-FDA Ivumela Uhlelo Lwezikulufo Zezinqe Ezihlanganisiwe Ngomshini

Uhlelo lwe-thoracolumbar pedicle screw, olubizwa ngegama lomkhiqizo i-OsteoCentric Spine MIS Pedicle Fastener System, olukhiqizwe yi-OsteoCentric Technologies, vele, “luhloselwe ukuqinisa nokuqinisa izingxenye zomgogodla ezigulini ezivuthiwe zamathambo njengokwelashwa okuhlangene kokungazinzi noma ukukhubazeka kwe-sacral okubukhali nokwesifuba, kwe-lumbar kanye nokungapheli”.
Ngokukhethekile, izikulufu ze-pedicle zenzelwe "ukulungiswa kwe-pedicle okungeyona eyesibeletho ngezinkomba ezilandelayo:
Uhlelo lwesikulufu se-thoracolumbosacral pedicle lufana kakhulu nohlelo lwesikulufu se-thoracolumbosacral pedicle lwe-Altus Partners, LLC.
Ngokusho kwe-OsteoCentric, i-OsteoCentric Pedicle Screw Fastener System™ izoba nobuchwepheshe be-UnifiMI. Esimemezelweni sabezindaba, u-Eric Brown, uMsunguli kanye ne-CEO ye-OsteoCentric, uchaze ukuthi, “Uhlelo lokunamathisela isiqu se-UnifiMI luzoba yilona kuphela uhlelo emakethe olusebenzisa ubuchwepheshe bokuhlanganisa okwenziwa ngomshini ukuqeda ukungazinzi kokufakelwa endaweni exhumanisa amathambo ne-implant.”
Ngokuvunyelwa kwe-FDA 510(k) kohlelo lwe-pedicle screw, i-OsteoCentric ithole umfutho owengeziwe emakethe ngokuvunyelwa kwe-FDA 510(k) kohlelo lwayo lwe-sacroiliac joint kanye nesikhwama sokukhulisa imali esiholwa yi-OnPoint Advisors. I-Foundation izosekela ukuhlanganiswa kwemishini kwezokwelapha amathambo kanye nodokotela bamazinyo.