Spine Implants - India CDSCO Medical Device Registration
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.
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Brand Name
SORATH, SORATH ORTHO
License Holder
M/s Universal Medicap LtdDevice Class
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
Brand: UMA SURGICALS, OSTEON, ORTHOSYS
UMA SURGICALS PRIVATE LIMITED
Pusher
Brand: SORATH, SORATH ORTHO
SIGMA SURGICAL PRIVATE LIMITED
Surgical Mallet
Brand: SORATH, SORATH ORTHO
SIGMA SURGICAL PRIVATE LIMITED
Depth Gauge
Brand: SORATH, SORATH ORTHO
SIGMA SURGICAL PRIVATE LIMITED
Alignment Guide
Brand: SORATH, SORATH ORTHO
SIGMA SURGICAL PRIVATE LIMITED
Reamer & its attachment
Brand: SORATH, SORATH ORTHO
SIGMA SURGICAL PRIVATE LIMITED
Retractor Holder
Brand: SORATH, SORATH ORTHO
SIGMA SURGICAL PRIVATE LIMITED
Instrument system for bipolar hip system
Brand: SORATH, SORATH ORTHO
SIGMA SURGICAL PRIVATE LIMITED
Bone Tap
Brand: SORATH, SORATH ORTHO
SIGMA SURGICAL PRIVATE LIMITED
Arthroscopic Instruments
Brand: SORATH, SORATH ORTHO
SIGMA SURGICAL PRIVATE LIMITED