Medtronic Sofamor Danek VERTEX™ Reconstruction system - HSA Registration DE0508546
Access comprehensive regulatory information for Medtronic Sofamor Danek VERTEX™ Reconstruction 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 DE0508546 and owned by Medtronic Sofamor Danek USA, Inc.. The device was registered on October 06, 2023.
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.
The VERTEX® Reconstruction System is intended to help provide immobilization and stabilization of spinal segments as an adjunct to fusion of the occipital, cervical, and/or upper thoracic spine. When intended as an adjunct to fusion of the occipitocervical spine, cervical spine, and the thoracic spine (Occiput-T3), the VERTEX® Reconstruction System is indicated for skeletally mature patients using allograft and/or autograft for the following: DDD (neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, spinal stenosis, fracture, dislocation, failed previous fusion, and/or tumors.