Pure Global

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_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.

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.

Free Database
Powered by Pure Global AI
CDSCO Registered
Class Class C
Total Hip replacement system
UID: IMP/MD/2019/000088_c0aa1ca53a245f19a42149602a09a398_69ced8f4d2fc465234c6605c4cad4039

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, โ€ข 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: โ€ข 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

Pure Global
DJ Fang

DJ Fang

MedTech Regulatory Expert

Need help with 30+ markets registration?

Pricing