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 IMP/MD/2019/000110_64b3d29b67bba15a7e03305c4287d606_753b70208a43e85314738c4d6996af9b. 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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CDSCO Registered

Class Class C

Spinal Fixation System

UID: IMP/MD/2019/000110_64b3d29b67bba15a7e03305c4287d606_753b70208a43e85314738c4d6996af9b

Brand Name

Non- Sterile

License Holder

M/s Zimmer India Pvt. Ltd

Device Class

Class C

Approving Authority

CDSCO

Product Information

The Dynesys Top-Loading Spinal 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

Class C

Plates for Trauma Fixation- Titanium Alloy

Brand: Non- Sterile

M/s Zimmer India Pvt. Ltd

Class C

Brand: CLS Spotorno Hip Stems

Class D