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Medtronic MASTERGRAFT® MATRIX EXT - HSA Registration DE0510131

Access comprehensive regulatory information for Medtronic MASTERGRAFT® MATRIX EXT in the Singapore medical device market through Pure Global AI's free database. This CLASS D medical device is registered under HSA registration number DE0510131 and owned by Medtronic Sofamor Danek USA, Inc.. The device was registered on December 11, 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.

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CLASS D
DE0510131
Medtronic MASTERGRAFT® MATRIX EXT
HSA Registration Number: DE0510131
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Product Description

MASTERGRAFT® Matrix is to be combined with autogenous bone marrow and is indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. MASTERGRAFT® Matrix is to be gently packed into bony voids or gaps of the skeletal system (e.g., the posterolateral spine, pelvis, ilium, and/or extremities). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. MASTERGRAFT® Matrix resorbs and is replaced with bone during the healing process.

Device Classification
Device Class
CLASS D
Medical Speciality Area
Orthopaedics
Registration Information
Registration Number
DE0510131
Registration Date
December 11, 2024
Retention Due Date
December 10, 2025
Product Owner
Short Name
Medtronic Sofamor Danek USA, Inc.
Address
1800 Pyramid Place, Memphis, TN 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)
MASTERGRAFT® MATRIX EXT
Model Identifier(s)
7610305