Unicompartmental Knee System - India CDSCO Medical Device Registration

Unicompartmental Knee System is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2018/000076_c5c541349c0c24cbdcc54d8b012a017d_916c012ea485d0d170a53fb46e4dc47d. 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

Unicompartmental Knee System

UID: IMP/MD/2018/000076_c5c541349c0c24cbdcc54d8b012a017d_916c012ea485d0d170a53fb46e4dc47d

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

Class C

Screws

Class C

Moisture Responsive Catheter Dressing

Brand: IV3000

Class B

Transparent dressing

Brand: IV3000

Class B