L&K Biomed PathLoc Lumbar Interbody Fusion Cage System - HSA Registration DE0509813
Access comprehensive regulatory information for L&K Biomed PathLoc Lumbar Interbody Fusion Cage System in the Singapore medical device market through Pure Global AI's free database. This CLASS C medical device is registered under HSA registration number DE0509813 and owned by L&K Biomed Co., Ltd. The device was registered on September 19, 2024.
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PathLoc Lumbar Interbody Fusion Cage System is indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous level(s) from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. These DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). This device is to be used with autogenous bone graft and/or allogenous bone graft composed of cancellous and/or corticocancellous bone. PathLoc Lumbar Interbody Fusion Cage System is to be used with supplemental fixation. Patients should have at least six (6) months of non-operative treatment prior to treatment with an intervertebral cage.