Spinal System - India CDSCO Medical Device Registration

Spinal System is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2019/000067_ef8f021e7311537e98cc9bb1be30fcab_2504dbfe00061cf6b3fbd3aa93873c29. This device is marketed under the brand name VLIFT. The license holder is Stryker 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 System

UID: IMP/MD/2019/000067_ef8f021e7311537e98cc9bb1be30fcab_2504dbfe00061cf6b3fbd3aa93873c29

Brand Name

VLIFT

License Holder

Stryker India Pvt. Ltd.,

Device Class

Class C

Approving Authority

CDSCO

Product Information

The ES2TM Spinal System is intended for percutaneous, posterior, non-cervical pedicle and non-pedicle fixation of the spine to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion for the following indications: Degenerative disc disease (VLIFT) (VLIFT); Spondylolithesis; Trauma (VLIFT); Spinal Stenosis; Curvatures (VLIFT); Tumor; Pseudoarthrosis; and Failed pervious fusion. The Titanium and VitalliumR rods from the Stryker Spine RADIUSR, MANTISR and MANTISR Redux Spinal Systems are intended to be used with the other components of the ES2TM Spinal System