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Revision Stem - India CDSCO Medical Device Registration

Revision Stem is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID MFG/MD/2022/000562_e64f8721fee52680b1d6b20e089cdd5f_1e73d1c4b2fd33c3ed285a27a5f5bc97. This device is marketed under the brand name Avatar /Signature/ Indus/ Avatar NX & Avatar NXT. The license holder is A V Processors Pvt. Ltd, and it is classified as Device Class Class C. The approving authority is Central Drug Standards Control Organization, West Zone.

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CDSCO Registered
Class Class C
Revision Stem
UID: MFG/MD/2022/000562_e64f8721fee52680b1d6b20e089cdd5f_1e73d1c4b2fd33c3ed285a27a5f5bc97

Brand Name

Avatar /Signature/ Indus/ Avatar NX & Avatar NXT

Device Class

Class C

Approving Authority

Central Drug Standards Control Organization, West Zone

Product Information

Long revision femoral stem for Revision Hip Arthroplasty is required when extensive bone loss is found in the proximal femur and primary prosthesis starts loosening. It is intended to achieve axial & rotational mechanical stability. Long revision femoral stem is required in the following clinical indications: Degenerative joint disease (Avatar /Signature/ Indus/ Avatar NX & Avatar NXT) Inflammatory joint disease (Avatar /Signature/ Indus/ Avatar NX & Avatar NXT) Rheumatoid arthritis Avascular Necrosis Osteoarthritis Proximal bone defects Bone fracture Failed previous surgery where pain Deformity Dis-function persist Post traumatic arthritis Revision of previously failed hip arthroplasty Instability

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