Fenestrated Screw - Viper Prime Spinal System - Sterile - India CDSCO Medical Device Registration

Fenestrated Screw - Viper Prime Spinal System - Sterile is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2022/000044_9366190c42bbf68973b4064c02dcd1b6_72ba171452f47e75f517cc1b2a3093a3. This device is marketed under the brand name Non-Sterile. The license holder is Johnson & Johnson Private Limited, and it is classified as Device Class Class C. The approving authority is CDSCO.

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CDSCO Registered

Class Class C

Fenestrated Screw - Viper Prime Spinal System - Sterile

UID: IMP/MD/2022/000044_9366190c42bbf68973b4064c02dcd1b6_72ba171452f47e75f517cc1b2a3093a3

Brand Name

Non-Sterile

License Holder

Johnson & Johnson Private Limited

Device Class

Class C

Approving Authority

CDSCO

Product Information

Titanium Alloy(Non-Sterile)-"The VIPER PRIME fenestrated screws are intended for use with CONFIDENCE High Viscosity Spinal Cement or the VERTECEM V+ Cement Kit to provide immobilization and stabilization of spinal segments in the treatment of acute and chronic instabilities or deformities of the thoracic, lumbar and sacral spine in patients with diminished bone quality (Non-Sterile). The screws are intended to provide temporary internal support and fixation while the fusion mass is consolidating or fracture is healing, or for palliative reconstruction in tumor patients."