HSA · registration DE0510131Medtronic MASTERGRAFT® MATRIX EXT
- Registration number
- DE0510131
- Model name
- MASTERGRAFT® MATRIX EXT
- Model identifier
- 7610305
- Registration date
- December 11, 2024
- Risk class
- Class D
- Product owner
- Medtronic Sofamor Danek USA, Inc.
- Registrant / registration holder
- MEDTRONIC INTERNATIONAL, LTD. (Singapore Branch)
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 address
- 1800 Pyramid Place, Memphis, TN 38132, United States
- Registrant address
- 50 PASIR PANJANG ROAD, #04-51, MAPLETREE BUSINESS CITY, Singapore 117384
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.