CDSCO UID IMP/MD/2019/000088_c0aa1ca53a245f19a42149602a09a398_79d171b786e23bedd079c473dde1a904
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_79d171b786e23bedd079c473dde1a904
- 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 indication specific to use of Anato Hip Stem with compatible Howmedica Osteonics Constrained Liners: • 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. The Anato Hip Stem is intended for cementless use only and is intended for total and hemi-arthroplasty procedures
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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_79d171b786e23bedd079c473dde1a904. 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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