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CDSCO UID IMP/MD/2020/000080_8396a03a5e9b6de92303612e03748d93_a72e7278f1063d173a05c4aa14cccbcb

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_a72e7278f1063d173a05c4aa14cccbcb
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 ANATOMIC PEEK™ PTC Cervical Fusion System is indicated for use in skeletally mature patients with degenerative disc disease (Mastergraft Granules) of the cervical spine with accompanying radicular symptoms at one disc level or two contiguous levels. DDD is defined as discogenic pain with degeneration of the disc confirmed by patient history and radiographic studies. The ANATOMIC PEEK™ PTC Cervical Fusion System is used to facilitate intervertebral body fusion in the cervical spine and is placed via an anterior approach from the C2-C3 disc space to the C7-T1 disc space using autograft or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft. The ANATOMIC PEEK™ PTC Cervical Fusion System is to be used with supplemental fixation. Patients should have at least six weeks of non-operative treatment prior to treatment with an intervertebral cage
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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_a72e7278f1063d173a05c4aa14cccbcb. 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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