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CDSCO UID MFG/MD/2022/000211_e7882fe12b098285a2ff381ea9c035b6_692cd57dbaef413cdc47002115ba0ead

Knee replacement system Tibia component

Perfect Medicare Products·Device Class Class D·India CDSCO
Registration details
UID
MFG/MD/2022/000211_e7882fe12b098285a2ff381ea9c035b6_692cd57dbaef413cdc47002115ba0ead
Device class
Class D
License holder
Perfect Medicare Products
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 ##PLACEHOLDER_0##, 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 ##PLACEHOLDER_0## 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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Knee replacement system Tibia component
Brand: Perfect
PERFECT MEDICARE PRODUCTS
Class D
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About this record

Knee replacement system Tibia component is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID MFG/MD/2022/000211_e7882fe12b098285a2ff381ea9c035b6_692cd57dbaef413cdc47002115ba0ead. 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.

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