Spinal Intervertebral Body Fixation Orthosis - India CDSCO Medical Device Registration
Spinal Intervertebral Body Fixation Orthosis is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2018/000446_a81da6ec3e559b36f0ec0077a1a5a7be_6e882165c60219b97fa2f244b4663fae. 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 DIVERGENCE™ Anterior Cervical Fusion System consists of a stand-alone interbody device indicated for use in anterior 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. The DIVERGENCE™ stand-alone cervical interbody device must be used with internal screw fixation. The DIVERGENCE™ stand-alone cervical interbody device is also required to be used with autogenous bone graft and is to be implanted via an open, anterior approach. This cervical device is to be used in patients who have had six weeks of non-operative treatment. Patients with previous non-fusion spinal surgery at involved level may be treated with the device
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