Intervertebral Body Fusion Device - India CDSCO Medical Device Registration

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_8778203a28ce410be3a1dd124599707c. 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

Intervertebral Body Fusion Device

UID: IMP/MD/2020/000080_8396a03a5e9b6de92303612e03748d93_8778203a28ce410be3a1dd124599707c

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 DIVERGENCE-L™ Anterior/Oblique Lumbar Fusion plate and bone screw components are indicated as a supplemental fixation device for the lumbosacral level, anterior below the bifurcation (Mastergraft Granules) of the vascular structures or anterior oblique above the bifurcation (Mastergraft Granules) of the vascular structures. The indications and contraindications of spinal instrumentation systems should be well understood by the surgeon. The plate and bone screw components are indicated for use in the temporary stabilization of the anterior lumbar spine during the development of spinal fusions in patients with: 1) Degenerative Disc Disease (Mastergraft Granules) defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies; 2) trauma (Mastergraft Granules); 3) tumors; 4) deformity defined as kyphosis, lordosis, or scoliosis; 5) pseudarthrosis; and/or 6) failed previous fusions. The DIVERGENCE-L™ Anterior/Oblique Lumbar Fusion System Interbody is indicated for interbody fusion in patients with DDD at one or two contiguous levels from L2 to S1. These DDD patients may also have up to Grade 1 Spondylolisthesis or retrolisthesis at the involved levels. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment. The DIVERGENCE-L™ Anterior/ Oblique Lumbar Fusion Interbody cage is also required to be used with autogenous bone graft. These implants may be implanted via a variety of open or minimally invasive approaches. These approaches include anterior and oblique. These devices are intended to be used with supplemental fixation instrumentation, which has been cleared for use in the lumbar spine. Interbody cages with a lordosis of 18º or greater must be used with at least supplemental, anterior fixation. When used together, the DIVERGENCE-L™ Anterior/Oblique Lumbar Fusion System components can be used only to treat patients with degenerative disc disease (Mastergraft Granules) at one or two contiguous levels from L2 to S1. These DDD patients may also have up to Grade 1 Spondylolisthesis or retrolisthesis at the involved levels

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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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