Saudi Arabia SFDA registration ME0000000280SFDAA00055
Kyphon V™ Osteo Introducer System 13GA
Saudi Arabia·Medical Device·Medtronic Sofamor Danek USA, Inc.·Class IIaActiveProduct information
Vertebral and Extremity Fracture Device
Product use
The KYPHON V™ Osteo Introducer® System is intended for percutaneous access to bone and the delivery of bone cement, including during kyphoplasty or vertebroplasty procedures.
Device classification
- Risk Class
- Class IIa
- Product Category
- Medical Device
- Product Type
- MD
Registration information
- Registration ID
- ME0000000280SFDAA00055
- Authorization ID
- MDMA-1-2016-0188
- Status
- Active
- Expire Date
- April 19, 2023
Manufacturer
- Manufacturer Name
- Medtronic Sofamor Danek USA, Inc.
Model information
- Model ID(s)
- VPT01A
Product accessories
[{'tradeName': 'KYPHON® Cement Delivery System, Cement Cartridges', 'description': 'Vertebral and Extremity Fracture Device', 'gmdn': '35809'}]
About this record
Access comprehensive regulatory information for Kyphon V™ Osteo Introducer System 13GA in the Saudi Arabia medical device market through Pure Global AI's free database. This Class IIa device is registered with Saudi Arabia SFDA under registration number ME0000000280SFDAA00055 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.
Free DatabasePowered by Pure Global AISFDA Official DataClass IIa