HSA · registration DE0509122

Medtronic Sofamor Danek Kyphon® Inflation Syringe

Name: Medtronic Sofamor Danek Kyphon® Inflation Syringe — HSA DE0509122
Creator: Medtronic Sofamor Danek USA, Inc.
Keywords: Medtronic Sofamor Danek Kyphon® Inflation Syringe, Medtronic Sofamor Danek Kyphon® Inflation Syringe, DE0509122, Orthopaedics, HSA

SingaporeOrthopaedicsClass BMedtronic Sofamor Danek USA, Inc.

Verified

Official record identity

Registration number: DE0509122
Model name: Medtronic Sofamor Danek Kyphon® Inflation Syringe
Model identifier: A08E
Registration date: March 28, 2024

Classification

Risk class: Class B
Published category: Orthopaedics

Published parties

Product owner: Medtronic Sofamor Danek USA, Inc.
Registrant / registration holder: MEDTRONIC INTERNATIONAL, LTD. (Singapore Branch)

Official description

The Kyphon® Inflation Syringe is intended to be used to inflate and deflate inflatable devices (including Inflatable Bone Tamps) and to measure the pressure within the inflatable device during the procedure.

Additional source fields

Product owner address: 1800 Pyramid Place, Memphis, TN 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.