Spine Implant
- UID
- MFG/MD/2020/000274_7f7e6aefdb08e44a88c70decf2b1de8d_c0675a40d00b584bed0b40811b5509d0
- Device class
- Class C
- Brand name
- HARDIK / ORTHOX
- License holder
- Hardik International Private Limited
- Approving authority
- Central Drug Standards Control Organization, Ahmedabad
- Product information
- Spinal system consists of a variety of shapes and sizes of rods, screw, transverse link as well as cages and cervical implants. Screw is intended for internal fixation of fractures and reconstruction of spinal bones, and for scoliosis. Examples of these internal fixations and reconstructions include compression fractures, intra-articular and extra-articular fractures, displaced fractures, osteotomies, non-unions and mal-unions. Different sizes are available with different design for better alignment an as per fracture
Spine Implant is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID MFG/MD/2020/000274_7f7e6aefdb08e44a88c70decf2b1de8d_c0675a40d00b584bed0b40811b5509d0. This device is marketed under the brand name HARDIK / ORTHOX. The license holder is Hardik International Private Limited, and it is classified as Device Class Class C. The approving authority is Central Drug Standards Control Organization, Ahmedabad.
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