WebGlycerol has been used as a DBM carrier since the introduction of Grafton by Osteotech over 20 years ago, and it has a demonstrated clinical history of safety. ... Hilibrand A, Yoon ST, Kavanagh E, Boden S. Grafton and local bone have comparable outcomes to iliac crest bone in instrumented single-level lumbar fusions. Spine (Phila Pa 1976);37 ... WebNov 11, 2005 · Osteotech has been working diligently with the FDA reviewers to clear all of our 510 (k) applications and expects that they will receive clearance by the Agency." Mr. Bauer continued, "Since its initial introduction in 1991, Grafton (R) DBM has been used in more than 600,000 procedures with an outstanding record of being both safe and effective.
Osteotech
WebThere is a long history of glycerol‐carrier demineralized bone matrices (DBM), such as Grafton® (Osteotech, Inc.) and Optium DBM® (LifeNet Health) used in Orthopaedic procedures. Here, human clinical evidence related to this class of implants is reported. What does the clinical evidence say? Web(a) one or more materials selected from the group consisting of fibroblast growth factors, vascular endothelial growth factors, endothelial cell growth factors, transforming growth factors, chitosan, bone, platelet derived endothelial-growth factors, placental growth factors, angiogenin, interleukin-8, granulocyte colony-stimulating growth factor, and supernatant … high 5ive oakland ca
International Medical Devices Database
WebDec 5, 2005 · Sam Owusu-Akyaw, Osteotech's President and Chief Operating Officer, stated, "The Grafton Plus(R) DBM Paste 510(k) for dental, oral and cranio/maxillofacial procedures is the second 510(k) clearance received by the Company from a series of five previously reported 510(k) applications that the Company has filed with the FDA covering … WebJan 5, 2015 · The donor site can be quickly and easily filled with OrthoBlast II (The Clinician’s Preference, Golden, CO), DBX (Musculoskeletal Transplant Foundation, Edison, NJ) or Grafton (Osteotech, Eatontown, … WebJan 13, 2006 · Osteotech has received US FDA 510(k) clearance for most of its family of Grafton demineralised bone matrix (DBM) products for use as a bone graft extender, bone graft substitute and bone void filler in orthopaedic indications. Covered in the firm's 510(k) application are its Grafton DBM Gel, Putty, Flex, Matrix, Crunch and Orthoblend. The … high 5 jsf