Joint Replacement Prosthesis - India CDSCO Medical Device Registration

Joint Replacement Prosthesis is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID MFG/MD/2023/000585_d56c3b0f426147c12a3bec35f2c2d830_f38ccf2acdca85f5333d3eec2c00765b. This device is marketed under the brand name Zenium. The license holder is Komal Health Care Pvt. Ltd., and it is classified as Device Class Class D. The approving authority is Central Drug Standards Control Organization, West Zone.

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CDSCO Registered

Class Class D

Joint Replacement Prosthesis

UID: MFG/MD/2023/000585_d56c3b0f426147c12a3bec35f2c2d830_f38ccf2acdca85f5333d3eec2c00765b

Brand Name

Zenium

License Holder

Komal Health Care Pvt. Ltd.

Device Class

Class D

Approving Authority

Central Drug Standards Control Organization, West Zone

Product Information

The Zenium BiPolar System is intended for use in combination with a Komal Healthcare Femoral Stem for primary or revision hemiarthroplasty of the hip, with/without the use of bone cement, for treatment of the following conditions: • Femoral neck and trochanteric fractures of theproximal femur • Osteonecrosis of the femoral head • Revision procedures where other devices or treatments for these indications have failed.

Class C

Brand: KAMGAUZE

Class B