Anterior Cervical Plate System - India CDSCO Medical Device Registration

Anterior Cervical Plate System is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2019/000240_39bf704482366627f10c74c858bfa5dd_998223148db75465954bba46b8f7b53e. This device is marketed under the brand name Polaris 5.5 spinal system - Connector. The license holder is Zimmer India 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

Anterior Cervical Plate System

UID: IMP/MD/2019/000240_39bf704482366627f10c74c858bfa5dd_998223148db75465954bba46b8f7b53e

Brand Name

Polaris 5.5 spinal system - Connector

License Holder

Zimmer India Private Limited

Device Class

Class C

Approving Authority

CDSCO

Product Information

The Trinica and Trinica Select Anterior Cervical Plate System is intended for anterior interbody screw fixation of the cervical spine at level C2–T1. The System is indicated for use in the temporary stabilization of the anterior spine during the development of cervical spinal fusions in patients with degenerative disc disease (Polaris 5.5 spinal system - Connector), trauma (Polaris 5.5 spinal system - Connector), tumors, deformity (Polaris 5.5 spinal system - Connector), pseudoarthrosis, and/or failed previous fusions

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