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_b7a3720dee253bbb32ed3aeee49e0aa5_0bd31d2aa2e54ecc533964ef342cfdb0. 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
Properly used, this system is intended for anterior interbody screw/plate fixation of the cervical spine. The indications and contraindications of spinal instrumentation systems should be well understood by the surgeon. 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
Wire, Surgical(Atlas cable System )
Brand: CD HORIZON SOLERA Spinal System
India Medtronic Private Limited
Mesh Surgical, Metal
Brand: CD HORIZON SOLERA Spinal System
India Medtronic Private Limited
System, Facet Screw Spinal Device
Brand: CD HORIZON SOLERA Spinal System
India Medtronic Private Limited
Spinal Interlaminal Fixation Orthosis
Brand: CD HORIZON SOLERA Spinal System
India Medtronic Private Limited
Artificial Cervical Disc
Brand: CD HORIZON SOLERA Spinal System
India Medtronic Private Limited
Spinal Intervertebral Body Fixation Orthosis
Brand: CD HORIZON SOLERA Spinal System
India Medtronic Private Limited
Orthosis, spinal pedicle fixation, for degenerative disc disease(CD Horizon Spinal System )
Brand: CD HORIZON SOLERA Spinal System
India Medtronic Private Limited
Intervertebral Body Fusion Device
Brand: CD HORIZON SOLERA Spinal System
India Medtronic Private Limited
Intervertebral Body Fusion Device
Brand: CD HORIZON SOLERA Spinal System
India Medtronic Private Limited
Intervertebral Body Fusion Device
Brand: CD HORIZON SOLERA Spinal System
India Medtronic Private Limited
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Recharger Kit
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Patient Cable
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BISX4 Module
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Complete Monitoring System
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Surgical Cable
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Controller
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