WebSep 10, 2024 · Lumbar intervertebral body fusion devices (L-IBFDs) are intended to provide stability to promote fusion in patients with a variety of lumbar pathologies. … WebTrade/Device Name: Calibrate LTX Interbody System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: MAX, PHM, OVD Dated: December 22, 2024 Received: December 23, 2024 Dear Neha Mohindroo: We have ...
Guidance for Industry and FDA Staff Class II Special Controls …
WebA component of an interbody fusion procedure is fixation. The NuVasive Modulus XLIF Interbody System is indicated for intervertebral body fusion of the spine in skeletally mature patients. The System is designed for use with autogenous and/or allogeneic bone graft comprised of cancellous and/or corticocancellous bone graft to facilitate fusion. WebThe intervertebral body fusion device is an implanted single or multiple-component spinal device made from a variety of materials, including titanium and polymers. negative impact of technology in finance
aprevo Intervertebral Body Fusion Device - Carlsmed
WebFeb 19, 2024 · Background: An unintended consequence following lumbar fusion is the development of adjacent segment disease (ASD). Oblique lumbar interbody fusion combined with posterior decompression (OLIF-PD) is another feasible option for ASD, and there is no literature report on this combined surgical strategy. Methods: A retrospective … WebJul 14, 2024 · 5.1 Intervertebral body fusion device assemblies are generally simple geometric-shaped devices which are often porous or hollow in nature. Their function is … WebFeb 19, 2024 · Background: An unintended consequence following lumbar fusion is the development of adjacent segment disease (ASD). Oblique lumbar interbody fusion … itil separation of duties