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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_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.

This page provides comprehensive regulatory information including complete registration details, license holder information, device classification, and related products. Pure Global AI offers free access to 71,807+ India medical device registrations, helping global MedTech companies identify partners, analyze markets, and discover business opportunities efficiently.

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CDSCO Registered
Class Class C
Total Hip replacement system
UID: IMP/MD/2019/000088_c0aa1ca53a245f19a42149602a09a398_79d171b786e23bedd079c473dde1a904

Brand Name

Trident II Acetabular Component System

Device Class

Class C

Approving Authority

CDSCO

Product Information

Noninflammatory degenerative joint disease, including osteoarthritis and avascular necrosis; โ€ข Rheumatoid arthritis; โ€ข Correction of functional deformity; โ€ข 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: โ€ข 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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