Fenestrated Screw Spinal System - India CDSCO Medical Device Registration
Fenestrated Screw Spinal System is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2018/000446_b95d732a10f5be367ab74704c910bd83_69c5c48b22015ae55a501d801ca85b4a. 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
In combination with other components of the CD HORIZON® Spinal System, the CD HORIZON® Fenestrated Screws are intended for posterior, non-cervical spinal fixation for the following indications: degenerative disc disease (Capstone Spinal System); ankylosing spondylitis, spondylolisthesis, trauma (Capstone Spinal System); spinal stenosis, failed previous fusion (Capstone Spinal System), deformity (Capstone Spinal System), revision surgery, and/or tumor. When used in conjunction with Fenestrated Screw Cement, the CD HORIZON® Fenestrated Screws are intended to provide enhanced pedicular fixation in patients with poor/compromised bone quality due to pathologies such as osteoporosis
Orthosis, spinal pedicle fixation for degenerative disc disease
Brand: Capstone Spinal System
India Medtronic Private Limited
Orthosis Cervical Pedicle Screw Spinal Fixation( INFINITY™ Occipito cervical-Upper Thoracic System )
Brand: Capstone Spinal System
India Medtronic Private Limited
Spinal Vertebral Body Replacement Device(Verte-Stack Spinal System )
Brand: Capstone Spinal System
India Medtronic Private Limited
Spinal Interlaminal Fixation Orthosis
Brand: Capstone Spinal System
India Medtronic Private Limited
Spinal Intervertebral Body Fixation Orthosis
Brand: Capstone Spinal System
India Medtronic Private Limited
Spinal Intervertebral Body Fixation Orthosis
Brand: Capstone Spinal System
India Medtronic Private Limited
Intervertebral Fusion Device with bone graft, cervical
Brand: Capstone Spinal System
India Medtronic Private Limited
Spinal Intervertebral Body Fixation Orthosis
Brand: Capstone Spinal System
India Medtronic Private Limited
Orthosis Cervical Pedicle Screw Spinal Fixation(INFINITY™ Occipito cervical-Upper Thoracic System )
Brand: Capstone Spinal System
India Medtronic Private Limited
Orthosis, spinal pedicle fixation, for degenerative disc disease(CD Horizon Spinal System )
Brand: Capstone Spinal System
India Medtronic Private Limited
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