Revision Knee Components
- UID
- MFG/MD/2018/000063_89a16f681f8283c27e0d6e3643e0b355_015570c8939d405af2f2270b2c68cf4a
- Device class
- Class C
- Brand name
- Stemmed Tibial Components & PCK Components
- 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 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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