VuePoint OCT Rod, Precurved - SFDA Registration ME0000005437SFDAA00224
Access comprehensive regulatory information for VuePoint OCT Rod, Precurved in the Saudi Arabia medical device market through Pure Global AI's free database. This Class II device is registered with Saudi Arabia SFDA under registration number ME0000005437SFDAA00224 and manufactured by NuVasive Inc..
This page provides complete registration details including product category (MD), manufacturer information, model details, and regulatory compliance data from the official Saudi Arabia SFDA medical device database. Pure Global AI offers free access to Saudi Arabia's complete medical device registry, helping global MedTech companies navigate SFDA regulations efficiently.
The NuVasive VuePoint II OCT System consists of screws, hooks, rods, offset connectors, rod to rod connectors, set screws, cross connectors, occipital plates and associated general instruments. Implant components are available in a variety sizes and can be rigidly locked into a variety of configurations to suit the individual pathology and anatomical conditions of the patient. The scope of this submission includes the introduction of 5.0 and 5.5 mm diameter multi axial bone screws, sterile implants, as well as minor modifications to the implant design since clearance of reference device NuVasive VuePoint II OCT System (K150474).
The NuVasive VuePoint OCT System and NuVasive VuePoint II OCT System are intended to provide immobilization and stabilization of spinal segments as an adjunct to fusion for the following acute and chronic instabilities of the craniocervical junction, the cervical spine (C1 to C7) and the thoracic spine (T1-T3): traumatic spinal fractures and/or traumatic dislocations; instability or deformity; failed previous fusions (e.g., pseudoarthrosis); tumors involving the cervical spine; and degenerative disease, including intractable radiculopathy and/or myelopathy, neck and/or arm pain of discogenic origin as confirmed by radiographic studies, and degenerative disease of the facets with instability.
[{'tradeName': 'VP Shaft, Occip Drill Bit Str', 'description': 'Drills, drill bits, and associated instruments are used to create a hole in the bone for the purpose of implanting a screw.\n', 'gmdn': '61325'}, {'tradeName': 'VuePoint Tap, Occipital Straight', 'description': 'Taps cut thread tracks in the bone for screw threads.', 'gmdn': '61325'}, {'tradeName': 'VuePoint Holder, Keel Plate', 'description': 'The implant holder is a multi-purpose tool that clasps onto the implant head in any situations where a firm grasp of the screw head is required. Cross Connection Holder instrument grips the fixed cross connectors for easy and controlled insertion.', 'gmdn': '61325'}, {'tradeName': 'VuePoint Guide, Occipital Drill', 'description': 'Guides and sleeves are used to align and guide the position and advancement of orthopedic instruments.', 'gmdn': '61325'}, {'tradeName': 'VuePoint Bender, Keel Plate Midline', 'description': 'Implant benders are designed to make fine adjustments to radial curves or contour in order to achieve the desired shape of plates and rods during a surgical procedure\n', 'gmdn': '61325'}]