HSA · registration DE0510363Medtronic Sofamor Danek Kyphon Assist™ Directional Cannula Size 3
SingaporeOrthopaedicsClass BMedtronic Sofamor Danek USA, Inc.
Official record identity
- Registration number
- DE0510363
- Model name
- Kyphon Assist™ Directional Cannula Size 3
- Model identifier
- T15S
- Registration date
- February 20, 2025
Classification
- Risk class
- Class B
Official value: CLASS B
Published parties
- Product owner
- Medtronic Sofamor Danek USA, Inc.
- Registrant / registration holder
- MEDTRONIC INTERNATIONAL, LTD. (Singapore Branch)
Official description
The Kyphon Assist™ Directional Cannula is intended for percutaneous access to bone.
Additional source fields
- Product owner address
- 1800 Pyramid Place, Memphis, Tennessee 38132, United States
- Registrant address
- 50 PASIR PANJANG ROAD, #04-51, MAPLETREE BUSINESS CITY, Singapore 117384
About this record
This page mirrors one row from HSA’s official registered-medical-device workbook. Product owner and registrant are separate published roles; neither is relabeled as the manufacturer. The official NOT_GENERATED value is retained when HSA does not publish a registration number, and the device name remains part of the stable record identity.