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Knee Replacement System Screw - India CDSCO Medical Device Registration

Knee Replacement System Screw is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID MFG/MD/2022/000211_14bbac321460e2fd339554caca8de625_9146bfc8b69e73c1a36d783ff8eea895. This device is marketed under the brand name osteoarthrosis. The license holder is Perfect Medicare Products, and it is classified as Device Class Class D. The approving authority is Central Drug Standards Control Organization, Ahmedabad.

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 D
Knee Replacement System Screw
UID: MFG/MD/2022/000211_14bbac321460e2fd339554caca8de625_9146bfc8b69e73c1a36d783ff8eea895

Brand Name

osteoarthrosis

Device Class

Class D

Approving Authority

Central Drug Standards Control Organization, Ahmedabad

Product Information

The System for Knee Arthroplasty Constrained is intended to replace the articular surface of the distal femur, proximal tibia and patellar surface during the surgical procedure of total knee joint replacement, performed in circumstances where this joint, in skeletally mature individuals, are impaired as a result of pathologies such as non-inflammatory degenerative joint disease (osteoarthrosis), traumatic arthritis, ankylosis of non-infectious origin and knee arthrodesis. The product is indicated for the replacement of the natural joint in primary knee arthroplasty procedures in patients who, according to the clinical evaluation, require medial-lateral, anterior-posterior and varus / valgus totally restricted stabilization due to inadequate function of ligaments needing (osteoarthrosis) wedges and/or extensions, due to poor quality or absence of bone stock. It is also indicated for the partial or total replacement of components in revision procedures of knee arthroplasty

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