I-FDA Igunyaza Uhlelo Oludidiyelwe Lwe-Pedicle Screw System

I-thoracolumbar pedicle screw system, igama lomkhiqizo i-OsteoCentric Spine MIS Pedicle Fastener System, eyenziwe yi-OsteoCentric Technologies, yebo, "ihloselwe ukulungiswa nokuqiniswa kwezingxenye zomgogodla ezigulini ezivuthiwe zamathambo njengokwelashwa okuhlangene kwe-acute kanye ne-thoracic, i-lumbar kanye ne-deconic instformity"
Ngokuqondile, izikulufu ze-pedicle zenzelwe "ukulungiswa kwe-pedicle okungeyona yomlomo wesibeletho kulezi zinkomba ezilandelayo:
Isistimu yesikulufu se-thoracolumbosacral pedicle empeleni iyafana ne-Altus Partners, LLC thoracolumbosacral pedicle screw system.
Ngokusho kwe-OsteoCentric, i-OsteoCentric Pedicle Screw Fastener System™ izofaka ubuchwepheshe be-UnifiMI. Enkulumweni yabezindaba, u-Eric Brown, Umsunguli kanye ne-CEO ye-OsteoCentric, wachaza, "Isistimu yokunamathisela i-UnifiMI stem izoba uhlelo olulodwa emakethe olusebenzisa ubuchwepheshe bokuhlanganiswa komshini ukuze kuqedwe ukungazinzi kokufakelwa kwe-bone-implant interface."
Ngokugunyazwa kwe-FDA 510(k) yesistimu yesikulufu se-pedicle, i-OsteoCentric izuze umfutho owengeziwe emakethe ngokugunyazwa kwe-FDA 510(k) ngohlelo lwayo oluhlanganyelwe lwe-sacroiliac kanye nesikhwama sokukhulisa inhlokodolobha esiholwa ngabacebisi be-OnPoint. I-Foundation izosekela ukuhlanganiswa kwemishini ku-orthopedics kanye nodokotela wamazinyo.