Spinal System - India CDSCO Medical Device Registration

Spinal System is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2020/000297_ef8f021e7311537e98cc9bb1be30fcab_cb22ebf4a9914fe4caea930cc08a3ea6. This device is marketed under the brand name Trabecular Metal Tibial Cone Augments. 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

Spinal System

UID: IMP/MD/2020/000297_ef8f021e7311537e98cc9bb1be30fcab_cb22ebf4a9914fe4caea930cc08a3ea6

Brand Name

Trabecular Metal Tibial Cone Augments

License Holder

Zimmer India Private Limited

Device Class

Class C

Approving Authority

CDSCO

Product Information

The TM Ardis® Interbody System is indicated for use as an intervertebral body fusion device at one or two contiguous levels in the lumbosacral region (Trabecular Metal Tibial Cone Augments) in the treatment of degenerative disc disease (Trabecular Metal Tibial Cone Augments) with up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(Trabecular Metal Tibial Cone Augments). DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. Patients with previous non-fusion spinal surgery at involved level may be treated with the device. Patients should be skeletally mature and have had six months of non-operative treatment. The TM Ardis® Interbody System device is implanted using a posterior or transforaminal approach and is intended to be used singly or in pairs with supplemental fixation

Class C

Brand: Lorenz® Surgical Instruments

Class B