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CDSCO UID IMP/MD/2020/000080_8396a03a5e9b6de92303612e03748d93_c8a29b366e8a325d43d661b903c40f08

Intervertebral Body Fusion Device

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·India CDSCO·Brand: Mastergraft Granules
Registration details
UID
IMP/MD/2020/000080_8396a03a5e9b6de92303612e03748d93_c8a29b366e8a325d43d661b903c40f08
Device class
Class C
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
Approving authority
CDSCO
Product information
The CAPSTONE® System is indicated for use with autogenous bone graft for interbody spinal fusion procedure in patients with degenerative disc disease (Mastergraft Granules) at one or two levels from L2-S1. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment. These implants may be implanted via an open or a minimally invasive posterior approach. Alternatively, these implants may also be implanted via a transforaminal approach. Alternatively, implants larger than 40 mm length should be implanted via direct lateral approach. These devices are intended to be used with supplemental fixation instrumentation, which has been cleared for use in the lumbar spine
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About this record

Intervertebral Body Fusion Device is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2020/000080_8396a03a5e9b6de92303612e03748d93_c8a29b366e8a325d43d661b903c40f08. 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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