Medtronic Sofamor Danek ANTERALIGN™ SPINAL SYSTEM WITH TITAN nanoLOCK™ SURFACE TECHNOLOGY - HSA Registration DE0509972
Access comprehensive regulatory information for Medtronic Sofamor Danek ANTERALIGN™ SPINAL SYSTEM WITH TITAN nanoLOCK™ SURFACE TECHNOLOGY in the Singapore medical device market through Pure Global AI's free database. This CLASS C medical device is registered under HSA registration number DE0509972 and owned by Medtronic Sofamor Danek USA, Inc.. The device was registered on October 24, 2024.
This page provides complete registration details including product owner information, registrant details, importer information, 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.
Intended to be used in spinal fusion procedures on skeletally mature patients with symptomatic Degenerative Disc Disease, degenerative spondylolisthesis, and/or spinal stenosis, at one or two contiguous levels from L2 to S1 whose condition requires the use of interbody fusion. These patients may also have up to Grade 1 Spondylolisthesis or retrolisthesis at the involved levels. These patients should have had six months of nonoperative treatment prior to treatment with this device. The system is intended to be used with autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft, for use with autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft and/or demineralized allograft bone with bone marrow aspirate or a combination thereof. The Anteralign™ LS interbody cage may be used as a stand-alone device or in conjunction with supplemental fixation.