Spinal Fixation System - India CDSCO Medical Device Registration

Spinal Fixation System is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID MFG/MD/2019/000061_64b3d29b67bba15a7e03305c4287d606_9f923df3f75f3d3e4b9a2d3a487a049a. This device is marketed under the brand name Fix/Mobile/Revision System And Tumor System. The license holder is SMIT MEDIMED 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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CDSCO Registered

Class Class C

Spinal Fixation System

UID: MFG/MD/2019/000061_64b3d29b67bba15a7e03305c4287d606_9f923df3f75f3d3e4b9a2d3a487a049a

Brand Name

Fix/Mobile/Revision System And Tumor System

License Holder

SMIT MEDIMED PVT LTD

Device Class

Class C

Approving Authority

Central Drug Standards Control Organization, Ahmedabad

Product Information

The SMPL spinal system is intended to help Provide immobilization and stabilization of spinal segments as an adjunct to fusion of the cervical, thoracic, lumbar, and/or sacral spine .The SMPL spinal system consists of a variety of shapes and sizes of rods, screw, transverse link as well as cages and cervical implants and are to be rigidly locked for getting better result. Screw is intended to use for internal fixation of fractures and reconstruction of spinal bones, and for scoliosis

Class C

Spinal Fixation System

Brand: Non- Sterile

M/s Zimmer India Pvt. Ltd

Class C

Brand: SMPL

Class A