Spine Implants
- UID
- MFG/MD/2023/000536_8c722585c179216a671b66f0e59bdd14_7441dd0df9bc02aeba7a61c2f164ab39
- Device class
- Class C
- Brand name
- SORATH, SORATH ORTHO
- License holder
- M/s Universal Medicap 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 (SORATH, SORATH ORTHO) for the following conditions: degenerative disc disease (SORATH, SORATH ORTHO); spondylolisthesis; spinal stenosis; trauma(SORATH, SORATH ORTHO); 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 (SORATH, SORATH ORTHO) spine. The uses of multiaxil screws (SORATH, SORATH ORTHO)/ 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 (SORATH, SORATH ORTHO) and create a rigid structure
Spine Implants is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID MFG/MD/2023/000536_8c722585c179216a671b66f0e59bdd14_7441dd0df9bc02aeba7a61c2f164ab39. This device is marketed under the brand name SORATH, SORATH ORTHO. The license holder is M/s Universal Medicap Ltd, and it is classified as Device Class Class C. The approving authority is Central Drug Standards Control Organization, Ahmedabad.
This page provides comprehensive regulatory information including complete registration details, license holder information, device classification, and related products. Pure Global AI offers free access to 71,807+ India medical device registrations, helping global MedTech companies identify partners, analyze markets, and discover business opportunities efficiently.