Spinal Vertebral Body Replacement Device - India CDSCO Medical Device Registration
Spinal Vertebral Body Replacement Device is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2019/000037_4ac0fea0cdcfd8a5066e53fb1f643c23_eb6ac98fee659b2a034dc55e8cd6821b. This device is marketed under the brand name CD HORIZON SOLERA Spinal System. The license holder is India Medtronic Private Limited, and it is classified as Device Class Class C. The approving authority is CDSCO.
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Brand Name
CD HORIZON SOLERA Spinal System
License Holder
India Medtronic Private LimitedDevice Class
Approving Authority
CDSCO
Product Information
The PYRAMESH® C TITANIUM MESH is for use in the thoracolumbar spine (CD HORIZON SOLERA Spinal System) to replace and restore the height of a diseased or damaged vertebral body caused by tumor and/or fracture. PYRAMESH® C TITANIUM MESH device is intended to be used with supplemental fixation. Allograft or autograft material may be used at the surgeon’s discretion
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