High Speed System - India CDSCO Medical Device Registration

High Speed System is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2023/001064_cbc7a71cb5f15d15451af8fb599718e9_e628fa42974f7226e84173c53cdced8c. This device is marketed under the brand name Midas REX MAZOR X Stealth Edition. 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

High Speed System

UID: IMP/MD/2023/001064_cbc7a71cb5f15d15451af8fb599718e9_e628fa42974f7226e84173c53cdced8c

Brand Name

Midas REX MAZOR X Stealth Edition

License Holder

India Medtronic Private Limited

Device Class

Class B

Approving Authority

CDSCO

Product Information

The Medtronic MR8 drill system is indicated for the incision/cutting, removal, drilling, and sawing of soft and hard tissue, bone, and biomaterials in Neurosurgical (Midas REX MAZOR X Stealth Edition); Ear, Nose, and Throat (Midas REX MAZOR X Stealth Edition), Maxillofacial, Orthopedic, Arthroscopic, Spinal, Sternotomy, and general surgical procedures. Additionally, the MR8 drill system is indicated for the incision/cutting, removal, drilling, and sawing of soft and hard tissue, bone, and biomaterials during open and minimally invasive spine procedures, which may incorporate application of various surgical techniques during the following lumbar spinal procedures: • Lumbar Microdiscectomy • Transforaminal Lumbar Interbody Fusion (Midas REX MAZOR X Stealth Edition) • Lumbar Stenosis Decompression • Anterior Lumbar Interbody Fusion (Midas REX MAZOR X Stealth Edition) • Posterior Lumbar Interbody Fusion (Midas REX MAZOR X Stealth Edition) • Direct Lateral Interbody Fusion (Midas REX MAZOR X Stealth Edition)