Saudi Arabia SFDA registration ME0000000535SFDAA00213
1.6 K-Wire, Olive
Saudi Arabia·Medical Device·Medartis AG·Class IIaActiveProduct information
Steel wire for skeletal transfixing of fractured bones
Product use
The APTUS fixation systems are used for fractures, osteotomies and arthrodesis of the hand, forearm, shoulder and foot. The APTUS cannulated compression screws are used for bone fractures, osteotomies and arthrodesis. The K-wires are used to hold bone fragments together.
Device classification
- Risk Class
- Class IIa
- Product Category
- Medical Device
- Product Type
- MD
Registration information
- Registration ID
- ME0000000535SFDAA00213
- Authorization ID
- MDMA-1-2020-0972
- Status
- Active
- Expire Date
- February 03, 2025
Manufacturer
- Manufacturer Name
- Medartis AG
Model information
- Model ID(s)
- A-5045.41/1 A-5045.42/1 A-5045.43/1 A-5045.44/1 A-5045.45/1 A-5045.46/1 A-5045.47/1
Product accessories
[]
About this record
Access comprehensive regulatory information for 1.6 K-Wire, Olive 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 ME0000000535SFDAA00213 and manufactured by Medartis AG.
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