Fa'amaonia e le FDA le fa'aogaina o masini fa'apipi'i pedicle Screw System

O le thoracolumbar pedicle screw system, igoa faʻailoga OsteoCentric Spine MIS Pedicle Fastener System, gaosia e OsteoCentric Technologies, o le mea moni, "faʻamoemoe mo le faʻamautuina ma le faʻamautuina o vaega ole vaʻaia i tagata mamaʻi skeletal e avea o se togafitiga tuʻufaʻatasia mo le faʻamaʻi ma le thoracic, lumbar ma le faʻamaʻi masani" le mautu.
Aemaise lava, o fao sikuila e fa'amoemoe mo le "fa'apipi'iina o vae e le o se fa'auma mo fa'ailoga nei:
O le faiga o le sikuila thoracolumbosacral pedicle e tutusa lelei ma le Altus Partners, LLC thoracolumbosacral pedicle screw system.
E tusa ai ma le OsteoCentric, o le OsteoCentric Pedicle Screw Fastener System ™ o le a faʻaalia ai tekinolosi UnifiMI. I se faʻasalalauga faʻasalalau, Eric Brown, Founder ma Pule Sili o OsteoCentric, na faʻamatalaina, "O le UnifiMI stem attachment system o le a naʻo le pau lea o le faiga i luga o le maketi e faʻaogaina ai tekinolosi tuʻufaʻatasia e faʻaumatia ai le le mautonu o le implant i le ponaivi-implant interface."
Faatasi ai ma le faʻatagaina o le FDA 510 (k) mo le faʻaogaina o le pedicle screw system, ua maua e OsteoCentric le malosi faʻaopoopo i le maketi ma le FDA 510 (k) faʻatagaina mo lona sacroiliac soʻotaga faʻapipiʻi ma se tupe faʻatupe tuputupu aʻe taʻitaʻia e OnPoint Advisors. O le a lagolagoina e le Faalapotopotoga Faavae le tuufaatasia o masini i foma'i ma'i nifo.


Taimi meli: Tes-20-2022