Revision Knee Components - Revision Tibial Base Plate(Evolve - Revision Tibial Base Plate ) - India CDSCO Medical Device Registration
Revision Knee Components - Revision Tibial Base Plate(Evolve - Revision Tibial Base Plate ) is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID MFG/MD/2018/000063_d36030979717260caae5ce7f0e8af5cc_c0011b9a1b1b06c5ce56806780866d68. This device is marketed under the brand name PCK Components. The license holder is Meril Healthcare Pvt. Ltd., and it is classified as Device Class Class C. The approving authority is Central Drug Standards Control Organization, Ahmedabad.
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Brand Name
PCK Components
License Holder
Meril Healthcare Pvt. Ltd.Device Class
Approving Authority
Central Drug Standards Control Organization, Ahmedabad
Product Information
Stemmed Tibial Components are designed to be used with Total Knee System, and is indicated for the following: • Severe knee joint pain, loss of mobility, and disability due to: rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis. • Correction of functional deformities. Post-traumatic loss of knee joint contour, particularly when there is patellofemoral erosion, dysfunction, and/or prior patellectomy. • Moderate valgus, varus, or flexion trauma. • Knee fractures untreatable by other methods • Revision surgery where sufficient bone stock and soft tissue integrity are present These Components are intended for cemented use only. This device is for single use only
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