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/2019/000496_c0aa1ca53a245f19a42149602a09a398_53523eb52e5460145b63a68a2018428f. This device is marketed under the brand name Femoral Stems. The license holder is M/s Stryker India Private Ltd.,, and it is classified as Device Class Class C. The approving authority is CDSCO.
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Brand Name
Femoral Stems
License Holder
M/s Stryker India Private Ltd.,Device Class
Approving Authority
CDSCO
Product Information
It is indicated for following indications • Non-inflammatory degenerative joint disease, including osteoarthritis and avascular necrosis. • Rheumatoid arthritis (Femoral Stems). • Correction of functional deformity. • Revision procedures where other treatments or device have failed and • Nonunion femoral neck fractures and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques
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