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/2018/000076_0fd2ba5dabd0832843ccf85d9aeffc94_8da1b7f79aee8a8e1b9f055a83d139ad. This device is marketed under the brand name JOURNEY. The license holder is Smith & Nephew Healthcare 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/2018/000076_0fd2ba5dabd0832843ccf85d9aeffc94_8da1b7f79aee8a8e1b9f055a83d139ad

Brand Name

JOURNEY

License Holder

Smith & Nephew Healthcare Pvt. Ltd.

Device Class

Class C

Approving Authority

CDSCO

Product Information

"Unicompartmental knee implants are indicated for restoring either compartment of a knee that has been affected by the following: * Noninflammatory degenerative joint disease including osteoarthritis, traumatic arthritis, or avascular necrosis; * Correction of functional deformity; * Revision procedures where other treatments or devices have failed; and * Treatment of fractures that are unmanageable using other techniques."