Spinal System - Mountaineer OCT - Rod -Non-Sterile -Titanium - India CDSCO Medical Device Registration
Spinal System - Mountaineer OCT - Rod -Non-Sterile -Titanium is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2022/000044_bd6342c4690cd2b73e6e16420dd2a53c_cb7d9fa6f1481181499a31210b1fb88a. This device is marketed under the brand name Non-Sterile. The license holder is Johnson & Johnson Private Limited, and it is classified as Device Class Class C. The approving authority is CDSCO.
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Brand Name
Non-Sterile
License Holder
Johnson & Johnson Private LimitedDevice Class
Approving Authority
CDSCO
Product Information
The SUMMIT SI OCT Spinal System and MOUNTAINEER OCT Spinal System are intended to promote fusion of the cervical spine and occipito-cervico-thoracic junction (Non-Sterile), and are indicated for the following: • ddd (Non-Sterile) • spondylolisthesis • spinal stenosis • fracture/dislocation • atlanto/axial fracture with instability • occipitocervical dislocation • revision of previous cervical spine surgery • tumors The occipital bone screws are limited to occipital fixation only.The use of the monoaxial and polyaxial screws is limited to placement in the upper thoracic spine (Non-Sterile) in treating thoracic conditions only. They are not intended to be placed in the cervical spine.The SONGER wire/cable system to be used with the SUMMIT SI OCT Spinal System and MOUNTAINEER OCT Spinal System allows for wire/cable attachment to the posterior cervical spine.The SUMMIT SI OCT System and MOUNTAINEER OCT Spinal System can also be linked to the ISOLA, MONARCH, MOSS MIAMI, VIPER and EXPEDIUM systems using the dual wedding band and axial connectors, and via dual diameter rods
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