Spinal Intervertebral Body Fixation Orthosis - India CDSCO Medical Device Registration
Spinal Intervertebral Body Fixation Orthosis is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2019/000037_a81da6ec3e559b36f0ec0077a1a5a7be_6a60bcfca62ab1106af4e0bceb2e0c73. 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 ZEVO™ Anterior Cervical Plate System is intended for anterior interbody screw fixation from C2 to T1. The system is indicated for use in the temporary stabilization of the anterior spine during the development of cervical spinal fusions in patients with: 1) degenerative disc disease (CD HORIZON SOLERA Spinal System), 2) trauma (CD HORIZON SOLERA Spinal System), 3) tumors, 4) deformity (CD HORIZON SOLERA Spinal System), 5) pseudarthrosis, and/or 6) failed previous fusions
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