Revision Knee Components - India CDSCO Medical Device Registration
Revision Knee Components is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID MFG/MD/2018/000063_89a16f681f8283c27e0d6e3643e0b355_015570c8939d405af2f2270b2c68cf4a. This device is marketed under the brand name Stemmed Tibial Components & PCK Components. The license holder is Meril Healthcare Pvt. Ltd. ,Ground & First Floor, Survey No.173/4 and First Floor, H1-H3, Meril Park, Survey No. 135/2/B & 174/2, Muktanand Marg, Chala, Vapi-396191 Gujarat, India. ,Valsad Gujarat ,396191 ,India, 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
Stemmed Tibial Components & PCK Components
Device Class
Approving Authority
Central Drug Standards Control Organization, Ahmedabad
Product Information
The DestikneeTM Stemmed Tibial Components are designed to be used with DestikneeTM-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
Revision Knee Components
Brand: Stemmed Tibial Components & PCK Components
M/s ELECTRO MAGNETIC INDUSTRIES
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Brand: Stemmed Tibial Components & PCK Components
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Bone Plates
Brand: Stemmed Tibial Components & PCK Components
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Brand: Stemmed Tibial Components & PCK Components
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Bone Screws
Brand: Stemmed Tibial Components & PCK Components
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Revision Knee Components
Brand: Stemmed Tibial Components & PCK Components
M/s AKSHAR GAMMA STERILES LLP
Total Knee system
Brand: Stemmed Tibial Components & PCK Components
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Guide Wire
Brand: Stemmed Tibial Components & PCK Components
Meril Healthcare Pvt. Ltd. ,Ground & First Floor, Survey No.173/4 and First Floor, H1-H3, Meril Park, Survey No. 135/2/B & 174/2, Muktanand Marg, Chala, Vapi-396191 Gujarat, India. ,Valsad Gujarat ,396191 ,India
Total Knee system
Brand: Stemmed Tibial Components & PCK Components
Meril Healthcare Pvt. Ltd. ,Ground & First Floor, Survey No.173/4 and First Floor, H1-H3, Meril Park, Survey No. 135/2/B & 174/2, Muktanand Marg, Chala, Vapi-396191 Gujarat, India. ,Valsad Gujarat ,396191 ,India
Total Knee system
Brand: Stemmed Tibial Components & PCK Components
Meril Healthcare Pvt. Ltd. ,Ground & First Floor, Survey No.173/4 and First Floor, H1-H3, Meril Park, Survey No. 135/2/B & 174/2, Muktanand Marg, Chala, Vapi-396191 Gujarat, India. ,Valsad Gujarat ,396191 ,India
Guide Wire
Brand: Stemmed Tibial Components & PCK Components
Total Knee system
Brand: Stemmed Tibial Components & PCK Components
Total Knee system
Brand: Stemmed Tibial Components & PCK Components
Total Knee system
Brand: Stemmed Tibial Components & PCK Components
Total Knee system
Brand: Stemmed Tibial Components & PCK Components
Total Knee system
Brand: Stemmed Tibial Components & PCK Components
Total Knee system
Brand: Stemmed Tibial Components & PCK Components
Total Knee system
Total Knee system
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