Intervertebral Fusion Device with bone graft, cervical - India CDSCO Medical Device Registration
Intervertebral Fusion Device with bone graft, cervical is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2018/000446_b4c653c3bc10f261e044d4a4502493ff_79d65c9476abcdfed8bdb19488a5fc5d. This device is marketed under the brand name Capstone Spinal System. The license holder is India Medtronic Private Limited, and it is classified as Device Class Class C. The approving authority is CDSCO.
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Brand Name
Capstone Spinal System
License Holder
India Medtronic Private LimitedDevice Class
Approving Authority
CDSCO
Product Information
The CORNERSTONEยฎ PSR device is indicated for cervical interbody fusion procedures in skeletally mature patients with cervical disc disease at one level from the C2-C3 disc to the C7-T1 disc. Cervical disc disease is defined as intractable radiculopathy and/or myelopathy with herniated disc and/or osteophyte formation on posterior vertebral endplates producing symptomatic nerve root and/or spinal cord compression confirmed by radiographic studies. This device is to be used in patients who have had six weeks of non-operative treatment. The CORNERSTONEยฎ PSR device is to be used with supplemental fixation. The CORNERSTONEยฎ PSR device is also required to be used with autograft
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