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_fb852153c0fca53c5e5dfd8e1ea336a9. This device is marketed under the brand name Non- Sterile. The license holder is M/s Zimmer India Pvt. Ltd, 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/2019/000110_fe2aab42d294ab713b1f6619411cb39d_fb852153c0fca53c5e5dfd8e1ea336a9

Brand Name

Non- Sterile

License Holder

M/s Zimmer India Pvt. Ltd

Device Class

Class C

Approving Authority

CDSCO

Product Information

The device is indicate for following:• Non-inflammatory degenerative joint disease (Non- Sterile), e.g., avascular necrosis, osteoarthritis, and inflammatory joint disease (Non- Sterile), 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

Class D

Hip System

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Johnson & Johnson Private Limited

Class D

Brand: CLS Spotorno Hip Stems

Class D