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_27b1ffa714fb90d6be39825dd32bb563. 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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CDSCO Registered

Class Class D

Hip System

UID: IMP/MD/2019/000110_fe2aab42d294ab713b1f6619411cb39d_27b1ffa714fb90d6be39825dd32bb563

Brand Name

CLS Spotorno Hip Stems

License Holder

M/s Zimmer India Pvt. Ltd

Device Class

Class D

Approving Authority

CDSCO

Product Information

The device is indicate for following:• Advanced wear of the joint due to degenerative, post-traumatic or rheumatic diseases. • Fractures or avascular necrosis.• Status following earlier operations, such as joint reconstruction (CLS Spotorno Hip Stems), arthrodesis, hemiarthroplasty or total hip prosthesis (CLS Spotorno Hip Stems), total knee prosthesis and status following other operations with prostheses, e.g., on shoulder or elbow joints, or following spinal surgery

Class D

Hip System

Brand: Biolox Delta- Revision Heads

Johnson & Johnson Private Limited

Class D

Brand: CLS Spotorno Hip Stems

Class D