Singapore HSA registration DE0510131
Medtronic MASTERGRAFT® MATRIX EXT
Singapore·CLASS D·Medtronic Sofamor Danek USA, Inc.·Registered December 11, 2024Device 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 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.
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
About this record
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.
Free DatabasePowered by Pure Global AIHSA Official DataCLASS D