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Medtronic Sofamor Danek Kyphon Assist™ Directional Cannula Size 3 - HSA Registration DE0510363

Access comprehensive regulatory information for Medtronic Sofamor Danek Kyphon Assist™ Directional Cannula Size 3 in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0510363 and owned by Medtronic Sofamor Danek USA, Inc.. The device was registered on February 20, 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.

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CLASS B
DE0510363
Medtronic Sofamor Danek Kyphon Assist™ Directional Cannula Size 3
HSA Registration Number: DE0510363
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Product Description

The Kyphon Assist™ Directional Cannula is intended for percutaneous access to bone.

Device Classification
Device Class
CLASS B
Medical Speciality Area
Orthopaedics
Registration Information
Registration Number
DE0510363
Registration Date
February 20, 2025
Retention Due Date
February 19, 2026
Product Owner
Short Name
Medtronic Sofamor Danek USA, Inc.
Address
1800 Pyramid Place, Memphis, Tennessee 38132, UNITED STATES
Registrant
Address
50 PASIR PANJANG ROAD, MAPLETREE BUSINESS CITY, #04-51, SINGAPORE 117384
Importer
Address
50 PASIR PANJANG ROAD, MAPLETREE BUSINESS CITY, #04-51, SINGAPORE 117384 50 PASIR PANJANG ROAD, MAPLETREE BUSINESS CITY, #04-51, SINGAPORE 117384
Model Information
Model Name(s)
Kyphon Assist™ Directional Cannula Size 3
Model Identifier(s)
T15S