L&K Biomed AccelFix Lumbar Expandable Cage System - HSA Registration DE0508901
Access comprehensive regulatory information for L&K Biomed AccelFix Lumbar Expandable 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 DE0508901 and owned by L&K Biomed Co., Ltd. The device was registered on January 26, 2024.
This page provides complete registration details including product owner information, registrant details, and regulatory compliance data from the official Singapore HSA medical device database. Pure Global AI offers free access to Singapore's complete medical device registry, helping global MedTech companies navigate HSA regulations efficiently.
AccelFix Lumbar Expandable 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. AccelFix Lumbar Expandable 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.

