Total Hip replacement system - India CDSCO Medical Device Registration
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_358290d3f02086c0acccd933e149eabe. 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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Brand Name
Trident II Acetabular Component System
License Holder
Stryker India Pvt. Ltd.,Device Class
Approving Authority
CDSCO
Product Information
The indications for use of the total hip replacement prostheses include: 1. noninflammatory degenerative joint disease, including osteoarthritis and avascular necrosis; 2. rheumatoid arthritis; 3. correction of functional deformity; 4. revision procedures where other treatments or devices have failed; and, 5. nonunions, femoral neck fractures, and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques. Additional indication specific to use of ACCOLADE II Femoral Stems with compatible Howmedica Osteonics Constrained Liners: 1. When the stem is to be used with compatible Howmedica Osteonics Constrained Liners, the device is intended for use in primary or revision patients at high risk of hip dislocation due to a history of prior dislocation, bone loss, soft tissue laxity, neuromuscular disease, or intra-operative instability. ACCOLADE II Femoral Stems are intended for cementless use only and are intended for total and hemiarthroplasty procedures
Total Hip replacement system
Brand: Antibiotic Simplex
M/s Stryker India Private Ltd.,
Total Hip replacement system
Brand: Femoral Stems
M/s Stryker India Private Ltd.,
Total Hip replacement system
Brand: Femoral Stems
M/s Stryker India Private Ltd.,
Total Hip replacement system-Cups and Shells
Brand: Trident II Acetabular Component System
Stryker India Pvt. Ltd.,
Hip replacement implant component-Liner(Modular Dual Mobility Insert )
Brand: Trident II Acetabular Component System
Stryker India Pvt. Ltd.,
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Brand: Trident II Acetabular Component System
Stryker India Pvt. Ltd.,
Total Hip replacement system
Brand: Trident II Acetabular Component System
Stryker India Pvt. Ltd.,
Total Hip replacement system
Brand: Trident II Acetabular Component System
Stryker India Pvt. Ltd.,
Total Hip replacement system
Brand: Trident II Acetabular Component System
Stryker India Pvt. Ltd.,
Total Hip replacement system
Brand: Trident II Acetabular Component System
Stryker India Pvt. Ltd.,
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