Subject: FDA
ulrich Medical USAtm Receives 510(k) Clearance for Flux-Ctm 3D Printed Porous Titanium Cervical Interbody Prior to NASS
ST. LOUIS, Oct. 13, 2022 /PRNewswire/ -- ulrich medical USA, Inc., a privately held medical device company focused on developing and commercializing musculoskeletal implant technologies in the United States, today announced the FDA has given 510(k) clearance of its Flux-C 3D printed porous titanium cervical interbody device.
"Surgeons have many options for cervical interbodies. The Flux-C porous titanium device offers one of the best in class with superior endplate contact and spaces for generous inter-device bone grafting. It is a welcomed complement to their superior array of expandable cages," said Patrick Maloney, M.D. newest member of ulrich Medical USA's Surgeon Advisory Board and its recently established Director of Deformity.
Flux-C is manufactured using a 3D printing process called direct metal laser sintering (DMLS). The interbodies are available in multiple parallel and lordotic options in various heights. These porous titanium devices are designed with a large graft window and a side window to allow for improved radiographic imaging.
Eric Lucas, Ph.D., ulrich Medical USA's Director of Technology states, "We are continuing to develop procedural solutions for reconstruction of all spinal pathologies in collaboration with our Surgeon Advisory Board. We strive to help our surgeons and distributors achieve New Heights and Beyond with integrity, through excellence in design, manufacturing and craftsmanship."
ulrich medical USA is privately held, celebrating its 110th year as a family-owned company. Recognized as a leader in vertebral body replacement, ulrich is dedicated to remaining independent and continuing to develop a complete spine solutions portfolio that results in superior patient outcomes for years to come. ulrich Medical USA is excited to be relocating its headquarters to the Dallas Fort-Worth area. ulrich medical's global headquarters is in Ulm, Germany.
SOURCE ulrich medical USA
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