Spinal fixation system - India CDSCO Medical Device Registration

Spinal fixation system is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2019/000240_d83560eca3b103d90cdf2eb3702ad12b_30cec05722845aeafa6da52d6d5cf29f. 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.

This page provides comprehensive regulatory information including complete registration details, license holder information, device classification, and related products. Pure Global AI offers free access to 71,807+ India medical device registrations, helping global MedTech companies identify partners, analyze markets, and discover business opportunities efficiently.

Free Database

CDSCO Registered

Class Class C

Spinal fixation system

UID: IMP/MD/2019/000240_d83560eca3b103d90cdf2eb3702ad12b_30cec05722845aeafa6da52d6d5cf29f

Brand Name

Polaris 5.5 spinal system - Connector

License Holder

Zimmer India Private Limited

Device Class

Class C

Approving Authority

CDSCO

Product Information

The Zyston Curve Interbody Spacer System is indicated for intervertebral body fusion at one level or two contiguous levels in the lumbar spine from L2 to S1 in patients with degenerative disc disease (Polaris 5.5 spinal system - Connector) with up to Grade 1 spondylolisthesis at the involved level(Polaris 5.5 spinal system - Connector). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment. The Zyston Curve Interbody Spacer System is designed for use with autograft to facilitate fusion and is intended for use with supplemental fixation systems cleared for use in the lumbar spine. The Zyston Curve Interbody Spacer System may also be implanted using the Accuvision System to provide the surgeon with a minimally invasive approach for posterior or posterolateral spinal surgery

Class C

Spinal fixation system

Brand: LnK, PathLoc-L

L&K Biomed India Private Limited

Class C

Brand: Lorenz® Surgical Instruments

Class B