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Singapore HSA registration DE0509273

Medtronic Sofamor Danek CENTERPIECE™ Plate Fixation System Bone Screw

Singapore flagSingapore·CLASS C·Medtronic Sofamor Danek USA, Inc.·Registered May 10, 2024
Device classification
Device Class
CLASS C
Medical Speciality Area
Orthopaedics
Registration information
Registration Number
DE0509273
Registration Date
May 10, 2024
Retention Due Date
May 09, 2026
Product description
The Centerpiece™ Plate Fixation System is intended to be implanted by healthcare professionals into (skeletally mature) adults with the following indications. The Centerpiece™ Plate Fixation System is intended for use in the lower cervical and upper thoracic spine (C3 to T3) in laminoplasty procedures. The Centerpiece™ Plate Fixation System is used to hold the graft material in place in order to prevent the graft material from expulsion or impinging the spinal cord.
Product Owner
Name
Medtronic Sofamor Danek USA, Inc.
Short Name
Medtronic Sofamor Danek USA, Inc.
Address
1800 Pyramid Place, Memphis, TN 38132, UNITED STATES
Registrant
Name
MEDTRONIC INTERNATIONAL, LTD.
Address
50 PASIR PANJANG ROAD, MAPLETREE BUSINESS CITY, #04-51, SINGAPORE 117384
Importer
Name
MEDTRONIC INTERNATIONAL TRADING PTE. LTD. MEDTRONIC INTERNATIONAL, LTD.
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)
CENTERPIECE Plate Fixation System Bone Screw CENTERPIECE Plate Fixation System Bone Screw CENTERPIECE Plate Fixation System Bone Screw CENTERPIECE Plate Fixation System Bone Screw CENTERPIECE Plate Fixation System Bone Screw CENTERPIECE Plate Fixation System Bone Screw CENTERPIECE Plate Fixation System Bone Screw CENTERPIECE Plate Fixation System Bone Screw CENTERPIECE Plate Fixation System Bone Screw CENTERPIECE Plate Fixation System Bone Screw CENTERPIECE Plate Fixation System Bone Screw CENTERPIECE Plate Fixation System Bone Screw CENTERPIECE Plate Fixation System Bone Screw CENTERPIECE Plate Fixation System Bone Screw
Model Identifier(s)
8532063 8532065 8532067 8532463 8532465 8532467 8532469 G8532063 G8532065 G8532067 G8532463 G8532465 G8532467 G8532469
About this record

Access comprehensive regulatory information for Medtronic Sofamor Danek CENTERPIECE™ Plate Fixation System Bone Screw in the Singapore medical device market through Pure Global AI's free database. This CLASS C medical device is registered under HSA registration number DE0509273 and owned by Medtronic Sofamor Danek USA, Inc.. The device was registered on May 10, 2024.

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.

Free DatabasePowered by Pure Global AIHSA Official DataCLASS C