Sterile Sleeves - India CDSCO Medical Device Registration

Sterile Sleeves is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2023/000578_711832085367e9133bd45d8d3fe7b84c_6313cf16362e8081f1f8f9d90a9b6a49. This device is marketed under the brand name for the Mazor X System. The license holder is India Medtronic Private Limited, and it is classified as Device Class Class B. The approving authority is CDSCO.

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CDSCO Registered

Class Class B

Sterile Sleeves

UID: IMP/MD/2023/000578_711832085367e9133bd45d8d3fe7b84c_6313cf16362e8081f1f8f9d90a9b6a49

Brand Name

for the Mazor X System

License Holder

India Medtronic Private Limited

Device Class

Class B

Approving Authority

CDSCO

Product Information

The Mazor X is indicated for precise positioning of surgical instruments or spinal implants during general spinal surgery. It may be used in open or minimally invasive or percutaneous procedures. Mazor X 3D imaging capabilities provide a processing and conversion of 2D fluoroscopic projections from standard C-Arms into volumetric 3D image. It is intended to be used whenever the clinician and/or patient benefits from generated 3D imaging of high contrast objects. The Mazor X navigation tracks the position of instruments, during spinal surgery, in relation to the surgical anatomy and identifies this position on diagnostic or intraoperative images of a patient. Note: The Sterile Sleeves shall be used together with the Mazor X System