Tibial Cone Augments - India CDSCO Medical Device Registration

Tibial Cone Augments is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2020/000297_ab00d7b273fc27c28c9228b1e8a71ea7_ad0ad086d469fb20e038cb907e3417b6. 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

Tibial Cone Augments

UID: IMP/MD/2020/000297_ab00d7b273fc27c28c9228b1e8a71ea7_ad0ad086d469fb20e038cb907e3417b6

Brand Name

Trabecular Metal Tibial Cone Augments

License Holder

Zimmer India Private Limited

Device Class

Class C

Approving Authority

CDSCO

Product Information

The Trabecular Metal Tibial Cone Augments are intended for use where severe degeneration, trauma, or other pathology of the knee joint indicates total knee arthroplasty. When used with the NexGen Complete Knee Solution – Rotating Hinge Knee (Trabecular Metal Tibial Cone Augments) System, the Trabecular Metal Tibial Cone Augments are for cemented use only. When used with the NexGen Complete Knee Solution – Legacy Constrained Condylar Knee System, the Trabecular Metal Tibial Cone Augments are for cementless or cemented use

Class C

Shim Component

Brand: Trabecular Metal Tibial Cone Augments

Zimmer India Private Limited

Class C

Brand: Lorenz® Surgical Instruments

Class B