Sam Brusco, Associate Editor09.21.23
Tyber Medical has earned several regulatory clearances for its K-Wires and Steinmann Pins:
U.S. Food and Drug Administration (FDA) and MDR clearance for its implantable K-Wires and Steinmann Pins made from 316L Stainless Steel and Titanium alloy Ti6AL4V ELI
MDR clearance for its sterile-packed, reusable guide wires and drill bits platform
The K-Wires and Steinmann Pins are available both sterile and non-sterile and come in multiple configurations, including combinations of trocar tip, diamond tip, fluted tip, partial thread, full thread, ball end, and flat end options. The wires and pins are available in lengths ranging from 60-450 mm and diameters between 0.6-6.35 mm.
"Our focus has always been on developing products that are innovative, efficient, and deliver unparalleled performance," Jeff Tyber, CEO of Tyber Medical, told the press. "Receiving the FDA and MDR clearance for these platforms is a testament to our rigorous pursuit of advancing patient care while helping our customers expand their brand."
David Hannah, Tyber’s CTO added, "With this clearance, our customers now have instant access to nearly every type of implantable K-Wire or Steinmann Pin that exists on the market, and we're not even finished with this product line yet."
Tyber also received a reusable indication for its K-Wires in Europe thanks to the recent acquisition of ADSM-Synchro Medical.
U.S. Food and Drug Administration (FDA) and MDR clearance for its implantable K-Wires and Steinmann Pins made from 316L Stainless Steel and Titanium alloy Ti6AL4V ELI
MDR clearance for its sterile-packed, reusable guide wires and drill bits platform
The K-Wires and Steinmann Pins are available both sterile and non-sterile and come in multiple configurations, including combinations of trocar tip, diamond tip, fluted tip, partial thread, full thread, ball end, and flat end options. The wires and pins are available in lengths ranging from 60-450 mm and diameters between 0.6-6.35 mm.
"Our focus has always been on developing products that are innovative, efficient, and deliver unparalleled performance," Jeff Tyber, CEO of Tyber Medical, told the press. "Receiving the FDA and MDR clearance for these platforms is a testament to our rigorous pursuit of advancing patient care while helping our customers expand their brand."
David Hannah, Tyber’s CTO added, "With this clearance, our customers now have instant access to nearly every type of implantable K-Wire or Steinmann Pin that exists on the market, and we're not even finished with this product line yet."
Tyber also received a reusable indication for its K-Wires in Europe thanks to the recent acquisition of ADSM-Synchro Medical.