5e939ba1-0919-4a76-a6af-9eda581c9496NewPublished12023-10-262023-10-18In Commercial Distribution00810135960885PrimaryGS1EARP INSTRUMENTSEARP-T-2235-0614047486041NVISION BIOMEDICAL TECHNOLOGIES, INC.1EARP, TRIAL 22X35X14 6° The EARP Interbody System is intended for intervertebral body fusion in the lumbar spine in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1 of the lumbosacral spine. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These patients should have had six months of non-operative treatment prior to treatment with an intervertebral cage. DDD patients may also have Grade 1 spondylolisthesis or retrolisthesis at involved levels. The device system must be used with supplemental fixation and autograft to facilitate fusion and is implanted via a posterolateral approach.falsetruefalsefalsefalsefalsetruefalsefalsefalsefalsefalsefalseLabeling does not contain MRI Safety Informationfalsefalse210-598-5641diana@nvisionbiomed.com44759General internal orthopaedic fixation system implantation kitA collection of instruments and devices intended to be used for the placement of an internal orthopaedic fixation system into or onto all types of bones (e.g., bones of limbs, spine, pelvis, or craniomaxillofacial). It is a non-dedicated device that includes various metallic and/or plastic reusable devices [e.g., retractors, rods, clamps, drills, pins, saws, screwdrivers, guides, trials, impactors] intended to be used for the implantation of any type of internal orthopaedic fixation system; the implant(s) is not included. This is a reusable device.falseActiveMDMInstrument, Manual, Surgical, General UseWidthDepthHeightfalsetrueMoist Heat or Steam Sterilization