Spinal Implant
- UID
- MFG/MD/2022/000020_824a29e2188d836c1ea153f79c0c894b_0f2467c6d9e2639b7e782128ec338721
- Device class
- Class C
- Brand name
- Zedex
- License holder
- Zedex Orthocare Pvt. Ltd.
- Approving authority
- Central Drug Standards Control Organization, Ahmedabad
- Product information
- Spinal Implant is intended to promote fusion of the cervical and thoracic spine (Zedex) for the following conditions: degenerative disc disease (Zedex); spondylolisthesis; spinal stenosis; trauma (Zedex); failed previous fusion; and/or tumors. The hooks and rods are also intended to provide stabilization to promote fusion following reduction of fracture/dislocation or trauma in the cervical/upper thoracic (Zedex) spine. The uses of multiaxil screws (Zedex)/ connectors are limited to placement in TI -T3 vertebrae for treating thoracic conditions only. Screws are not intended to be placed in the cervical spine
Spinal Implant is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID MFG/MD/2022/000020_824a29e2188d836c1ea153f79c0c894b_0f2467c6d9e2639b7e782128ec338721. This device is marketed under the brand name Zedex. The license holder is Zedex Orthocare Pvt. Ltd., and it is classified as Device Class Class C. The approving authority is Central Drug Standards Control Organization, Ahmedabad.
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