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/2019/000110_fe2aab42d294ab713b1f6619411cb39d_33dd412415818acfd9e7f241f65bf836. This device is marketed under the brand name CLS Spotorno Hip Stems. The license holder is M/s Zimmer India Pvt. Ltd, and it is classified as Device Class Class D. The approving authority is CDSCO.
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Brand Name
CLS Spotorno Hip Stems
License Holder
M/s Zimmer India Pvt. LtdDevice Class
Approving Authority
CDSCO
Product Information
This device is indicated for:• Non-inflammatory degenerative joint disease (CLS Spotorno Hip Stems), e.g., avascular necrosis, osteoarthritis, and inflammatory joint disease (CLS Spotorno Hip Stems), e.g., rheumatoid arthritis. • Failed previous surgery where pain, deformity, or dysfunction persists. • Revision of previously failed hip arthroplasty• Total hip replacements may be considered for younger patients if any unequivocal indication outweighs the risks associated with the age of the patient and modified demands regarding activity and hip joint loading are assured. This includes severely handicapped patients with multiple joint involvements, for whom an immediate need of hip mobility leads to an expectation of significant improvement in the quality of their lives
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