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CDSCO UID IMP/MD/2019/000110_64b3d29b67bba15a7e03305c4287d606_ce63c89f34efb510091b039186768f69

Spinal Fixation System

M/s Zimmer India Pvt. Ltd·Device Class Class C·India CDSCO·Brand: Non- Sterile
Registration details
UID
IMP/MD/2019/000110_64b3d29b67bba15a7e03305c4287d606_ce63c89f34efb510091b039186768f69
Device class
Class C
Brand name
Non- Sterile
License holder
M/s Zimmer India Pvt. Ltd
Approving authority
CDSCO
Product information
The Dynesys Dynamic Stabilization System is indicated to provide spinal alignment and dynamic re-stabilization in skeletally mature patients up to 5 contiguous levels from L1-S1 (Non- Sterile). The system is intended to be used without bone graft for the following indications- Primary discopathy (Non- Sterile) and spondylarthrosis in combination with:• Hypomobile discopathy; degenerative retrolisthesis (Non- Sterile)• Hypermobile discopathy; degenerative antelisthesis (Non- Sterile)• Degenerative spondylolisthesis (Non- Sterile)• Mono- or multisegmental lumbar stenosis with or without degenerative spondylolisthesis
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About this record

Spinal Fixation System is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2019/000110_64b3d29b67bba15a7e03305c4287d606_ce63c89f34efb510091b039186768f69. This device is marketed under the brand name Non- Sterile. The license holder is M/s Zimmer India Pvt. Ltd, and it is classified as Device Class Class C. The approving authority is CDSCO.

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