Spinal Vertebral Body Replacement Device - India CDSCO Medical Device Registration

Spinal Vertebral Body Replacement Device is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2022/000659_4ac0fea0cdcfd8a5066e53fb1f643c23_bb172ac8a7983ddfe0d9483f188bb99e. This device is marketed under the brand name Verte-Stack Spinal System. The license holder is India Medtronic 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

Spinal Vertebral Body Replacement Device

UID: IMP/MD/2022/000659_4ac0fea0cdcfd8a5066e53fb1f643c23_bb172ac8a7983ddfe0d9483f188bb99e

Brand Name

Verte-Stack Spinal System

License Holder

India Medtronic Private Limited

Device Class

Class C

Approving Authority

CDSCO

Product Information

The VERTE-STACK® Spinal System is a vertebral body replacement device intended for use in the thoracolumbar spine (Verte-Stack Spinal System) to replace a collapsed, damaged, or unstable vertebral body due to tumor or trauma (Verte-Stack Spinal System). The VERTE-STACK® Spinal System is to be used with supplemental fixation. Specifically, the VERTE-STACK® device is to be used with the Medtronic ZPLATE II™ Anterior Fixation System, the DYNA-LOK CLASSIC® Spinal System, the VANTAGE™ Anterior Fixation System, the TSRH® Spinal System, the CD HORIZON® Spinal System and/or the GDLH® Spinal System. Additionally, the VERTE-STACK® device is intended to be used with bone graft