Knee System - India CDSCO Medical Device Registration

Knee System is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2019/000110_0fd2ba5dabd0832843ccf85d9aeffc94_f4994b3fada34e64d1c49711def11406. 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

Knee System

UID: IMP/MD/2019/000110_0fd2ba5dabd0832843ccf85d9aeffc94_f4994b3fada34e64d1c49711def11406

Brand Name

Non- Sterile

License Holder

M/s Zimmer India Pvt. Ltd

Device Class

Class C

Approving Authority

CDSCO

Product Information

This device is indicated for: • Unicompartmental non-inflammatory degenerative joint disease (Non- Sterile), e.g., avascular necrosis, osteoarthritis, and arthritis secondary to a variety of diseases, and anomalies. • Failed previous surgery where pain, deformity, or dysfunction persists. • Passively correctable valgus-varus deformity and moderate flexion contracture. • These devices are indicated for cemented use only

Class D

Brand: Non- Sterile

M/s Zimmer India Pvt. Ltd

Class C

Brand: CLS Spotorno Hip Stems

Class D