Total Hip Replacement System - India CDSCO Medical Device Registration
Total Hip Replacement System is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2020/000244_7edc1cd988319870135df90e8e850e8f_b39a57cdd8e466992e72d29e7a165bf5. This device is marketed under the brand name Zimtron Modular Head. The license holder is Zimmer India Private Limited, and it is classified as Device Class Class D. The approving authority is CDSCO.
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Brand Name
Zimtron Modular Head
License Holder
Zimmer India Private LimitedDevice Class
Approving Authority
CDSCO
Product Information
The CPT Hip System is indicated for cemented use in: • Patients suffering from severe hip pain and disability due to rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis, collagen disorders, avascular necrosis of the femoral head, and nonunion of previous fractures of the femur. • Patients with congenital hip dysplasia, protrusio acetabuli, or slipped capital femoral epiphysis. • Patients suffering from disability due to previous fusion. • Patients with previously failed endoprostheses and/or total hip components in the affected extremity. • Patients with acute femoral neck fractures.
Total Hip Replacement System
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Meril Healthcare Pvt. Ltd. ,Ground & First Floor, Survey No.173/4 and First Floor, H1-H3, Meril Park, Survey No. 135/2/B & 174/2, Muktanand Marg, Chala, Vapi-396191 Gujarat, India. ,Valsad Gujarat ,396191 ,India
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