Spine Implants
- UID
- MFG/MD/2021/000150_8c722585c179216a671b66f0e59bdd14_bdfecc2ccc1902c71a1e18df27522a63
- Device class
- Class C
- Brand name
- Zeus Bone Plate
- License holder
- ZEUS ORTHOCARE PVT. LTD.
- Approving authority
- Central Drug Standards Control Organization, Ahmedabad
- Product information
- The Spinal Implant System is intended to promote fusion of the cervical and thoracic spine (Zeus Bone Plate) for the following conditions: degenerative disc disease (Zeus Bone Plate); spondylolisthesis; spinal stenosis; trauma(Zeus Bone Plate); 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 (Zeus Bone Plate) spine. The uses of multiaxil screws (Zeus Bone Plate)/ 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. Titanium rods are provided in various lengths and are used to connect pedicle screws (Zeus Bone Plate) and create a rigid structure. The rods are connected to the implants by interference with the rod saddle and held into position by the locking caps. all screws, hook, rods and cage are used as single implants
Spine Implants is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID MFG/MD/2021/000150_8c722585c179216a671b66f0e59bdd14_bdfecc2ccc1902c71a1e18df27522a63. This device is marketed under the brand name Zeus Bone Plate. The license holder is ZEUS 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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