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/2019/000423_0fd2ba5dabd0832843ccf85d9aeffc94_c4a3007ed1e18c30e8693227509eb727. The license holder is Johnson & Johnson Private Limited, and it is classified as Device Class Class D. The approving authority is CDSCO.

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CDSCO Registered

Class Class D

Knee System

UID: IMP/MD/2019/000423_0fd2ba5dabd0832843ccf85d9aeffc94_c4a3007ed1e18c30e8693227509eb727

License Holder

Johnson & Johnson Private Limited

Device Class

Class D

Approving Authority

CDSCO

Product Information

Femoral##PLACEHOLDER_0##-"The P.F.C.® Sigma® PS150 Rotating Platform ##PLACEHOLDER_0## Total Knee System is indicated for cemented use in cases of osteoarthritis and rheumatoid arthritis. The RPF inserts and Sigma PS150 femoral components are indicated where a higher than normal degree of post-operative flexion is required. The Sigma PS150 femoral components and RPF rotating platform inserts can be used with either the MBT prosthesis or the MBT revision prosthesis and modular revision tibial components which are indicated for revision of failed knee prostheses."

Class C

Knee System

Brand: JOURNEY

Smith & Nephew Healthcare Pvt. Ltd.

Class C

Brand: PROLENE*

Class D