Spine System - Rod - Non Sterile - India CDSCO Medical Device Registration

Spine System - Rod - Non Sterile is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2022/000044_f33fedaa0c2c36e516a653354a04b459_1373ab3a245d19da7fbb337f02db3cb1. 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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CDSCO Registered

Class Class C

Spine System - Rod - Non Sterile

UID: IMP/MD/2022/000044_f33fedaa0c2c36e516a653354a04b459_1373ab3a245d19da7fbb337f02db3cb1

Brand Name

Non-Sterile

License Holder

Johnson & Johnson Private Limited

Device Class

Class C

Approving Authority

CDSCO

Product Information

The SYMPHONY OCT System is intended to provide immobilization and stabilization of spinal segments as an adjunct to fusion for the following acute and chronic instabilities of the craniocervical junction, the cervical spine (Non-Sterile) and the upper thoracic spine (Non-Sterile): • Traumatic spinal fractures and/or traumatic dislocations; • Instability or deformity; • Failed previous fusions (Non-Sterile); • Tumors involving the cervical/thoracic spine; and • Degenerative spine disease. When used in the pediatric population, the SYMPHONY OCT System is intended to provide immobilization and stabilization of spinal segments as an adjunct to fusion for the following acute and chronic instabilities of the craniocervical junction, the cervical spine (Non-Sterile) and the upper thoracic spine (Non-Sterile): • Traumatic spinal fractures and/or traumatic dislocations; • Instability or deformity; and • Tumors involving the cervical/thoracic spine. The SYMPHONY OCT System is also intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the cervical spine in whom life expectancy is of insufficient duration to permit achievement of fusion

Class C

Spinal System - Monarch - Connector -Non-Sterile - Titanium

Brand: Non-Sterile

Johnson & Johnson Private Limited

Class C

Brand: PROLENE*

Class D