Hip System - India CDSCO Medical Device Registration

Hip System is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2020/000244_fe2aab42d294ab713b1f6619411cb39d_6b402d097723745a40e928fdce7494ee. This device is marketed under the brand name Multipolar® Bipolar Cup – Liner. 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

Hip System

UID: IMP/MD/2020/000244_fe2aab42d294ab713b1f6619411cb39d_6b402d097723745a40e928fdce7494ee

Brand Name

Multipolar® Bipolar Cup – Liner

License Holder

Zimmer India Private Limited

Device Class

Class C

Approving Authority

CDSCO

Product Information

Use of the MultiPolar® Bipolar Cup is indicated in: • Fracture dislocation of the hip • Elderly, debilitated patients when a total hip replacement is contraindicated • Irreducible fractures in which adequate fixation cannot be obtained • Certain high subcapital fractures and comminuted femoral neck fractures in the aged • Non-union of femoral neck fractures • Secondary avascular necrosis of the femoral head • Pathological fractures of the femoral neck • Osteoarthritis in which the femoral head is primarily affected

Class D

Hip System

Brand: Biolox Delta- Revision Heads

Johnson & Johnson Private Limited

Class D

Brand: Lorenz® Surgical Instruments

Class B