Fenestrated Screw System - Non-Sterile -Titanium - India CDSCO Medical Device Registration

Fenestrated Screw System - Non-Sterile -Titanium is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2022/000044_d795b42e6dd6f6240e8794e4261a55de_5fdc3ef2615936f515a4a25887bb2407. 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 System - Non-Sterile -Titanium

UID: IMP/MD/2022/000044_d795b42e6dd6f6240e8794e4261a55de_5fdc3ef2615936f515a4a25887bb2407

Brand Name

Non-Sterile

License Holder

Johnson & Johnson Private Limited

Device Class

Class C

Approving Authority

CDSCO

Product Information

The VIPER® Fenestrated Screw System is intended to be used with the CONFIDENCE SPINAL CEMENT SYSTEM® or the V-MAX® Mixing and Delivery System and the VERTEBROPLASTIC® Radiopaque Resinous Material 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). It is intended to provide temporary internal support and fixation while fusion mass is consolidating or fracture is healing or for the palliative reconstruction of the tumor patients