Minimally Invasive Pedicle Screw System - India CDSCO Medical Device Registration

Minimally Invasive Pedicle Screw System is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2019/000240_fbc52bf751e96e17696bbccaa0c26e08_7c8e2ad9f1a5d34975da89fc0fbfdde7. 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

Minimally Invasive Pedicle Screw System

UID: IMP/MD/2019/000240_fbc52bf751e96e17696bbccaa0c26e08_7c8e2ad9f1a5d34975da89fc0fbfdde7

Brand Name

Polaris 5.5 spinal system - Connector

License Holder

Zimmer India Private Limited

Device Class

Class C

Approving Authority

CDSCO

Product Information

When intended for pedicle screw fixation from T1 – S1, the indications include immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar and sacral spine: degenerative disc disease (Polaris 5.5 spinal system - Connector), degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, deformities or curvatures (Polaris 5.5 spinal system - Connector), tumor and failed previous fusion. As a pedicle screw system placed between L3 and S1, the indications include Grade 3 or Grade 4 spondylolisthesis, when utilizing autograft or allograft, when affixed to the posterior lumbosacral spine, and intended to be removed after the solid fusion is established.

Class C

Brand: Lorenz® Surgical Instruments

Class B