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_b7a3720dee253bbb32ed3aeee49e0aa5_2ddf6e97a4749a2e49bdff56450d4fbc. 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 Distractable WAVE Cage is indicated for interbody fusion with autogenous bone graft in patients with degenerative disc disease (Capstone Spinal System) 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. These implants may be implanted via an open or a minimally invasive posterior approach. These implants are to be used with autogenous bone graft. These devices are intended to be used with supplemental fixation instrumentation, which has been cleared by the FDA for use in the lumbar spine
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