4fc3db66-35dc-4a10-9dfc-4efc9fce9111NewPublished12023-07-032023-06-23In Commercial Distribution00819824028691PrimaryGS1KODIAK PL TL GRAFT BLOCK04-07G04-07G080474650MET 1 TECHNOLOGIES, LLC1The Met One Technologies Kodiak Lumbar Spacer System is a lumbar intervertebral body fusion device that is implanted into the vertebral body space to improve stability of the spine while supporting fusion. The Kodiak Lumbar Spacer System may be implanted bilaterally using a posterior (PLIF) approach, or as a single device employing a transformational (TLIF) approach. The implants have a central endplate window to permit packing of autograft and/or allograft bone, teeth on the superior and inferior surfaces, and lateral windows for radiographic visualization. The implants are additively manufactured from Ti-6Al-4V ELI and are available in a variety of heights, footprints, and lordotic configurations to suit individual patient anatomy.falsefalsefalsefalsefalsefalsetruetruetruefalsefalsefalsefalseLabeling does not contain MRI Safety Informationtruefalse9154726762yone@met1tech.comK23085100047743Bone graft packing blockA device designed to tightly compact (pack) an implant with a bone graft material (e.g., autologous, allogeneic, xenogeneic, or of synthetic origin) prior to the implantation of the implant. It is typically a small, box-shaped device consisting of two parts, a frame to hold the implant to be filled and a fitted lid that stabilizes the implant while it is being filled. The packing of the implant is done manually, typically with an impactor. This is a reusable device.falseActiveMAXIntervertebral Fusion Device With Bone Graft, LumbarfalsetrueMoist Heat or Steam Sterilization