Hip replacement system – Liners / Inserts / Cup - India CDSCO Medical Device Registration

Hip replacement system – Liners / Inserts / Cup is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2020/000112_85038889035eb930b2bd969faf69f344_c1af1331e12c7e549145a51cbc877643. This device is marketed under the brand name Total Knee Replacement. The license holder is Stryker 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

Hip replacement system – Liners / Inserts / Cup

UID: IMP/MD/2020/000112_85038889035eb930b2bd969faf69f344_c1af1331e12c7e549145a51cbc877643

Brand Name

Total Knee Replacement

License Holder

Stryker India Pvt. Ltd.,

Device Class

Class C

Approving Authority

CDSCO

Product Information

It is intended for use for total hip arthroplasty in conditions such as painful, disabling joint disease of the hip resulting from degenerative arthritis, rheumatoid arthritis , post traumatic arthritis or late stage avascular necrosis , revision of previous unsuccessful femoral head replacement cup arthroplasty or other procedures where arthrodesis or alternative reconstructive techniques are less likely to achieve satisfactory results, where bone stock is of poor quality or inadequate for other reconstructive techniques as indicated by deficiencies of the acetabulum

Class C

Tibial Trays/Baseplate

Brand: Total Knee Replacement

Stryker India Pvt. Ltd.,

Class C

Brand: Ideal Eyes

Class B

Endoscopic Cameras and Image Processors

Class B

Urology and Gynecology Systems

Class B