Centinel Spine prodisc® C SK - HSA Registration DE0510691
Access comprehensive regulatory information for Centinel Spine prodisc® C SK in the Singapore medical device market through Pure Global AI's free database. This CLASS C medical device is registered under HSA registration number DE0510691 and owned by Centinel Spine, Inc.. The device was registered on May 07, 2025.
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.
prodisc® C SK implants are used to replace a cervical intervertebral disc and to restore disc height and segmental motion. The prodisc® C SK Total Disc Replacement is indicated in skeletally mature patients for reconstruction of a single disc from C3-C7 following discectomy for intractable symptomatic cervical disc disease (SCDD). Symptomatic cervical disc disease is defined as neck or arm (radicular) pain and/or a functional/neurological deficit with at least one of the following conditions confirmed by imaging (CT, MRI, or x-rays): herniated nucleus pulposus, spondylosis (defined by the presence of osteophytes), and/or loss of disc height. The prodisc® C SK Total Disc Replacement is implanted via an open anterior approach. Patients receiving the prodisc® C SK Total Disc Replacement should have failed at least six weeks of nonoperative treatment prior to implantation of the prodisc® C SK Total Disc Replacement.