Interbody Fusion Device - India CDSCO Medical Device Registration

Interbody Fusion Device is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2020/000080_2034a808dc8fa1676e20bbffd9aea723_abb714720350e53f69cb78ce2e4670b5. This device is marketed under the brand name Mastergraft Granules. The license holder is India Medtronic Private Limited ,Shed No. 3, Block No. 1, Survey No. 389, 400/2A & 2C, Pudur Main Road, Kuthambakkam - 600124, Poonamallee Taluk, Tiruvallur District ,Tiruvallur Tamil Nadu ,600124 ,India, and it is classified as Device Class Class C. The approving authority is CDSCO.

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CDSCO Registered

Class Class C

Interbody Fusion Device

UID: IMP/MD/2020/000080_2034a808dc8fa1676e20bbffd9aea723_abb714720350e53f69cb78ce2e4670b5

Brand Name

Mastergraft Granules

License Holder

India Medtronic Private Limited ,Shed No. 3, Block No. 1, Survey No. 389, 400/2A & 2C, Pudur Main Road, Kuthambakkam - 600124, Poonamallee Taluk, Tiruvallur District ,Tiruvallur Tamil Nadu ,600124 ,India

Device Class

Class C

Approving Authority

CDSCO

Product Information

The CRESCENT® System is indicated for interbody spinal fusion procedures in skeletally mature patients with degenerative disc disease (Mastergraft Granules) from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level. The CRESCENT® System is to be used with autogenous bone graft

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Other Products from India Medtronic Private Limited ,Shed No. 3, Block No. 1, Survey No. 389, 400/2A & 2C, Pudur Main Road, Kuthambakkam - 600124, Poonamallee Taluk, Tiruvallur District ,Tiruvallur Tamil Nadu ,600124 ,India

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