Saudi Arabia SFDA registration ME0000000280SFDAA00039

INFINITYT Occipitocervical Upper Thoracic System Partially Threaded Multi Axial Screw

Saudi Arabia·Medical Device·Medtronic Sofamor Danek USA, Inc.·Class IIActive

Product information

Partially Threaded Multi Axial Screw

Product use

The INFINITY™ OCT System is intended to provide immobilization and stabilization of spinal segments as an adjunct to fusion for acute and chronic instabilities of the craniocervical junction, the cervical spine (C1 to C7), and the thoracic spine from T1-T3 also intended to restore the integrity of the spinal column even in the absence of fusion for a limited time in patients with advanced stage tumors involving the cervical spine in whom life expectancy is of insufficient duration to permit achievement of fusion.

Device classification

Risk Class: Class II
Product Category: Medical Device
Product Type: MD

Registration information

Registration ID: ME0000000280SFDAA00039
Authorization ID: MDMA-1-2019-0285
Status: Active
Expire Date: May 11, 2025

Manufacturer

Manufacturer Name: Medtronic Sofamor Danek USA, Inc.

Model information

Model ID(s): G3603008, G3603010, G3603012, G3603014, G3603016, G3603018, G3603020, G3603022, G3603024, G3603026, G3603028, G3603030, G3603032, G3603034, G360PT3518, G360PT3520, G360PT3532, G360PT3534, G360PT3536, G360PT3538, G360PT3540, G360PT4018, G360PT4020, G360PT4032, G360PT4034, G360PT4036, G360PT4038, G360PT4040, 360PT3522, 360PT3524, 360PT3526, 360PT3528, 360PT3530, 360PT4022, 360PT4024, 360PT4026, 360PT4028, 360PT4030

Product accessories

[{'tradeName': 'INFINITY™ OCT System Navigated Instrument Tray', 'description': 'Orthopedic Surgical Instruments and Accessories\n', 'gmdn': 'N/A'}, {'tradeName': 'OC Rod Pusher / COUNTER TORQUE', 'description': 'Orthopedic Surgical Instruments and Accessories', 'gmdn': 'N/A'}, {'tradeName': 'INFINITY™ OCT System Hook Instrument Module', 'description': 'Orthopedic Surgical Instruments and Accessories', 'gmdn': 'N/A'}, {'tradeName': 'INFINITY™ OCT System OC-C2 Implant Tray', 'description': 'Orthopedic Surgical Instruments and Accessories', 'gmdn': 'N/A'}, {'tradeName': 'INFINITY™ OCT System Complex Instrument Tray', 'description': 'Orthopedic Surgical Instruments and Accessories', 'gmdn': 'N/A'}, {'tradeName': 'INFINITY™ OCT System Instrument module', 'description': 'Orthopedic Surgical Instruments and Accessories', 'gmdn': 'N/A'}, {'tradeName': 'INFINITY™ OCT System C3-C7 Implant Module: 3.5 MAS Caddy', 'description': 'Orthopedic Surgical Instruments and Accessories', 'gmdn': 'N/A'}, {'tradeName': 'INFINITY™ OCT System C3-C7 Implant Module: 3.5 MAS Caddy Lid', 'description': 'Orthopedic Surgical Instruments and Accessories', 'gmdn': 'N/A'}, {'tradeName': 'INFINITY™ OCT System C3-C7 Implant Module: connector caddy', 'description': 'Orthopedic Surgical Instruments and Accessories', 'gmdn': 'N/A'}, {'tradeName': 'INFINITY™ OCT System C3-C7 connector caddy Lid', 'description': 'Orthopedic Surgical Instruments and Accessories', 'gmdn': 'N/A'}, {'tradeName': 'INFINITY™ OCT System C3-C7 Implant Module: Set Screw Caddy', 'description': 'Orthopedic Surgical Instruments and Accessories', 'gmdn': 'N/A'}, {'tradeName': 'INFINlTY™ OCT System C3-C7 Implant Module: Pre-Cut Rod Caddy', 'description': 'Orthopedic Surgical Instruments and Accessories', 'gmdn': 'N/A'}, {'tradeName': 'INFINlTY™ OCT System C3-C7 Implant Module: Pre-Cut Rod Caddy Lid', 'description': 'Orthopedic Surgical Instruments and Accessories', 'gmdn': 'N/A'}, {'tradeName': 'INFINITY™ OCT System OC Screw Caddy Lid', 'description': 'Orthopedic Surgical Instruments and Accessories', 'gmdn': 'N/A'}, {'tradeName': 'INFINlTY™ OCT System C3-C7 Implant Module: Set Screw Caddy Lid', 'description': 'Orthopedic Surgical Instruments and Accessories', 'gmdn': 'N/A'}]

About this record

Access comprehensive regulatory information for INFINITYT Occipitocervical Upper Thoracic System Partially Threaded Multi Axial Screw 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 ME0000000280SFDAA00039 and manufactured by Medtronic Sofamor Danek USA, Inc..

This page provides complete registration details including product category (Medical Device), 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.

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