Total Hip replacement system-Inserts - India CDSCO Medical Device Registration

Total Hip replacement system-Inserts is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2019/000088_735b366d69d595747bbe7adf836a3954_080b713712bb5c99f6243390b6ffc2d0. This device is marketed under the brand name Trident II Acetabular Component System. 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

Total Hip replacement system-Inserts

UID: IMP/MD/2019/000088_735b366d69d595747bbe7adf836a3954_080b713712bb5c99f6243390b6ffc2d0

Brand Name

Trident II Acetabular Component System

License Holder

Stryker India Pvt. Ltd.,

Device Class

Class C

Approving Authority

CDSCO

Product Information

Painful, disabling joint disease of the hip resulting from: degenerative arthritis, rheumatoid arthritis, posttraumatic arthritis or late stage avascular necrosis. • Revision of previous unsuccessful femoral head replacement, cup arthroplasty or other procedure. • Clinical management problems where arthrodesis or alternative reconstructive techniques are less likely to achieve satisfactory results. • Where bone stock is of poor quality or is inadequate for other reconstructive techniques as indicated by deficiencies of the acetabulum