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CDSCO UID IMP/MD/2019/000088_c0aa1ca53a245f19a42149602a09a398_69ced8f4d2fc465234c6605c4cad4039

Total Hip replacement system

Stryker India Pvt. Ltd.,·Device Class Class C·India CDSCO·Brand: Trident II Acetabular Component System
Registration details
UID
IMP/MD/2019/000088_c0aa1ca53a245f19a42149602a09a398_69ced8f4d2fc465234c6605c4cad4039
Device class
Class C
Brand name
Trident II Acetabular Component System
License holder
Stryker India Pvt. Ltd.,
Approving authority
CDSCO
Product information
Noninflammatory degenerative joint disease, including osteoarthritis and avascular necrosis; • Rheumatoid arthritis; • Correction of functional deformity; • Revision procedures where other treatments or devices have failed; and, • Nonunions, femoral neck fractures, and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques. Additional indications specific to the RESTORATION Modular Hip System: • The RESTORATION Modular Hip System is intended for primary and revision total hip Arthroplasty as well as in the presence of severe proximal bone loss. These femoral stems are designed to be press fit into the proximal femur
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About this record

Total Hip replacement system is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2019/000088_c0aa1ca53a245f19a42149602a09a398_69ced8f4d2fc465234c6605c4cad4039. 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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