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CDSCO UID IMP/MD/2018/000446_b95d732a10f5be367ab74704c910bd83_69c5c48b22015ae55a501d801ca85b4a

Fenestrated Screw Spinal System

India Medtronic Private Limited·Device Class Class C·India CDSCO·Brand: Capstone Spinal System
Registration details
UID
IMP/MD/2018/000446_b95d732a10f5be367ab74704c910bd83_69c5c48b22015ae55a501d801ca85b4a
Device class
Class C
Brand name
Capstone Spinal System
License holder
India Medtronic Private Limited
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
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About this record

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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