knee system - India CDSCO Medical Device Registration

knee system is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2019/000456_a1bc04a8527b949006f1caaa94569c5e_02af8c9adcfd87932e4327c563021923. This device is marketed under the brand name Vanguard Knee System - tibial Component. 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

knee system

UID: IMP/MD/2019/000456_a1bc04a8527b949006f1caaa94569c5e_02af8c9adcfd87932e4327c563021923

Brand Name

Vanguard Knee System - tibial Component

License Holder

Zimmer India Private Limited

Device Class

Class C

Approving Authority

CDSCO

Product Information

1. 1. Painful and disabled knee joint resulting from osteoarthritis, rheumatoid arthritis, and/or traumatic arthritis where one or more compartments are involved. 2. 2. Correction of varus, valgus, or posttraumatic deformity 3. 3. Correction or revision of unsuccessful osteotomy, arthrodesis, or failure of previous joint replacement procedure The Regenerex femoral augments are indicated for use with the Vanguard Total Knee System. The Regenerex tibial augments are indicated for use with standard and offset Biomet Tibial Trays. Femoral components and tibial tray components with porous coatings are indicated for cemented and uncemented biological fixation application. Non-coated (Vanguard Knee System - tibial Component) devices and all-polyethylene patellar components are indicated for cemented application only. 4. Regenerex components* are intended only for uncemented biologic fixation application. The Vanguard DA 360 components are not intended for use with the Vanguard PS Open Box Porous Femoral Components. The Vanguard DA 360 components are not approved for sale in the United States or Canada

Class C

Knee System

Brand: Vanguard Knee System - tibial Component

Zimmer India Private Limited

Class C

Brand: Lorenz® Surgical Instruments

Class B