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CDSCO UID IMP/MD/2018/000446_b4c653c3bc10f261e044d4a4502493ff_79d65c9476abcdfed8bdb19488a5fc5d

Intervertebral Fusion Device with bone graft, cervical

India Medtronic Private Limited·Device Class Class C·India CDSCO·Brand: Capstone Spinal System
Registration details
UID
IMP/MD/2018/000446_b4c653c3bc10f261e044d4a4502493ff_79d65c9476abcdfed8bdb19488a5fc5d
Device class
Class C
Brand name
Capstone Spinal System
License holder
India Medtronic Private Limited
Approving authority
CDSCO
Product information
The CORNERSTONE® 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 CORNERSTONE® PSR device is to be used with supplemental fixation. The CORNERSTONE® PSR device is also required to be used with autograft
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About this record

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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