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Hip replacement implant component-Liner(Modular Dual Mobility Insert ) - India CDSCO Medical Device Registration

Hip replacement implant component-Liner(Modular Dual Mobility Insert ) is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2019/000088_e248bb719275779976252712610129e0_07098a3db5075e466000107cfeef103c. 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
Hip replacement implant component-Liner(Modular Dual Mobility Insert )
UID: IMP/MD/2019/000088_e248bb719275779976252712610129e0_07098a3db5075e466000107cfeef103c

Brand Name

Trident II Acetabular Component System

Device Class

Class C

Approving Authority

CDSCO

Product Information

The indications for use for total hip arthroplasty include: 3. Noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis; 4. Rheumatoid arthritis; 5. Correction of functional deformity; 6. Revision procedures where other treatments or devices have failed; and, 7. Treatment of on-union, femoral neck and trochanteric fractures of the proximal femur with head 8. involvement that are unmanageable using other techniques. 9. Dislocation risks

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