Total Knee system - India CDSCO Medical Device Registration
Total Knee system is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID MFG/MD/2022/000066_4b570bbbb8ab6449ebfa8268ad893b86_d1021b8b468765d3ff1ec05c410abae1. This device is marketed under the brand name Stemmed Tibial Components & PCK Components. The license holder is M/s AKSHAR GAMMA STERILES LLP, and it is classified as Device Class Class C. The approving authority is Central Drug Standards Control Organization, West Zone.
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Brand Name
Stemmed Tibial Components & PCK Components
License Holder
M/s AKSHAR GAMMA STERILES LLPDevice Class
Approving Authority
Central Drug Standards Control Organization, West Zone
Product Information
The Total Knee System is indicated for replacement of total knee or knee components for patients with severe knee pain and disability due to: • Painful degenerative knee joint disease caused by: rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis. • Correction of functional deformities. • Post-traumatic loss of knee joint contour, particularly when there is patella femoral erosion, dysfunction or prior patellectomy. • Moderate valgus, varus, or flexion trauma. • Knee fractures untreatable by other methods
Revision Knee Components
Brand: Stemmed Tibial Components & PCK Components
M/s ELECTRO MAGNETIC INDUSTRIES
Intramedullary Nails
Brand: Stemmed Tibial Components & PCK Components
M/s ELECTRO MAGNETIC INDUSTRIES
Bone Plates
Brand: Stemmed Tibial Components & PCK Components
M/s ELECTRO MAGNETIC INDUSTRIES
Total Knee system
Brand: Stemmed Tibial Components & PCK Components
M/s ELECTRO MAGNETIC INDUSTRIES
Bone Screws
Brand: Stemmed Tibial Components & PCK Components
M/s ELECTRO MAGNETIC INDUSTRIES
Revision Knee Components
Brand: Stemmed Tibial Components & PCK Components
M/s AKSHAR GAMMA STERILES LLP
Total Knee system
Brand: For Gamma Sterilization
Agrosurg Irradiators (India) Pvt. Ltd.
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
Oxidized Regenerated Cellulose Haemostat
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Absorbable Gelatin Sponge
Brand: SURGISPON, MEDISPONGE, UNISPONGE, BLOXANG, GEL-SPONGE, HEMOGEL, HEMOSPONGE, PERISPONGE™, SURGIGEL, TOP DENT DENTOSTAN, EVOSPON, CLINIX, HYGITECH, R&S, KENTDENTAL, OCTOCALOGEN, TOPISPON, SURGISENZ, MVG, SCHMIDT, ILION DENTAL, GELASPON, GELASPON KDM, PROCLINIC, BESTDENT, STELLIGEL, BIOSPONGE, FLOSPONG, SMI-SPON, MEDISPON, CLINISPON, I-SPONGE, MERIFEIM, DSI SPONGE, CHIRUSPONGE, MERIFOAM, IDSPONGE, DENTOSPON, KARESPON, HEMOSPON, ALPHASPON
Absorbable Gelatin Sponge with Colloidal Silver
Brand: SURGISPON, MEDISPONGE, UNISPONGE, BLOXANG, GEL-SPONGE, HEMOGEL, HEMOSPONGE, PERISPONGE™, SURGIGEL, TOP DENT DENTOSTAN, EVOSPON, CLINIX, HYGITECH, R&S, KENTDENTAL, OCTOCALOGEN, TOPISPON, SURGISENZ, MVG, SCHMIDT, ILION DENTAL, GELASPON, GELASPON KDM, PROCLINIC, BESTDENT, STELLIGEL, BIOSPONGE, FLOSPONG, SMI-SPON, MEDISPON, CLINISPON, I-SPONGE, MERIFEIM, DSI SPONGE, CHIRUSPONGE, MERIFOAM, IDSPONGE, DENTOSPON, KARESPON, HEMOSPON, ALPHASPON
Natural Non-Absorbable Silk Surgical Suture U.S.P.
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Cu 250 Sterilized Intrauterine Contraceptive Device
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Powered Endoscopic Linear Cutter
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Ligating Clip
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Absorbable sterilized surgical Catgut Chromic suture U.S.P
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