CDSCO UID MFG/MD/2019/000196_a904a2a8566c8548eeb17a5b746eadea_253b84c84a1a7dc0888636aa2ee19f16
TOTAL KNEE REPLACEMENT - PATELLAR & TIBIAL TRAY COMPONENT
DKSORTHO & SHARMA PHARMACEUTICAL PRIVATE LIMITED·Device Class Class C·India CDSCO·Brand: SHARMA, SPCPL, DKSORTHO, DKSORTHO MEDICAL DEVICES
Registration details
- UID
- MFG/MD/2019/000196_a904a2a8566c8548eeb17a5b746eadea_253b84c84a1a7dc0888636aa2ee19f16
- Device class
- Class C
- Brand name
- SHARMA, SPCPL, DKSORTHO, DKSORTHO MEDICAL DEVICES
- License holder
- DKSORTHO & SHARMA PHARMACEUTICAL PRIVATE LIMITED
- Approving authority
- Central Drug Standards Control Organization, Ahmedabad
- Product information
- TOTAL KNEE REPLACEMENT (SHARMA, SPCPL, DKSORTHO, DKSORTHO MEDICAL DEVICES) IS INTENDEDTO PROVIDE INCREASED PATIENT MOBILITY AND REDUCE PAIN BY REPLACING THE DAMAGED KNEE JOINT ARTICULATION INPATIENTS WHERE THERE IS EVIDENCE OF SUFFICIENT SOUND BONE TO SEAT AND SUPPORT THE COMPONENTS. TKR MAY BE CONSIDERED FOR YOUNGERPATIENTSIF, IN THE OPINION OFTHESURGEON ANUNEQUIVOCAL INDICATIONFORTKROUTWEIGHS THERISKS ASSOCIATEDWITH THEAGEOFTHEPATIENT, ANDIF LIMITEDDEMANDS REGARDINGACTIVITY ANDKNEE JOINT LOADING CANBEASSURED.THIS INCLUDES SEVERELYCRIPPLEDPATIENTSWITH MULTIPLEJOINT INVOLVEMENT FORWHOMAGAININKNEE MOBILITYMAYLEADTOANEXPECTATION OF SIGNIFICANT IMPROVEMENT INTHEQUALITYOF THEIRLIVES. TKRISINDICATED FORASEVERELY PAINFUL AND/ORDISABLED JOINTFROM OSTEOARTHRITIS
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About this record
TOTAL KNEE REPLACEMENT - PATELLAR & TIBIAL TRAY COMPONENT is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID MFG/MD/2019/000196_a904a2a8566c8548eeb17a5b746eadea_253b84c84a1a7dc0888636aa2ee19f16. This device is marketed under the brand name SHARMA, SPCPL, DKSORTHO, DKSORTHO MEDICAL DEVICES. The license holder is DKSORTHO & SHARMA PHARMACEUTICAL PRIVATE LIMITED, and it is classified as Device Class Class C. The approving authority is Central Drug Standards Control Organization, Ahmedabad.
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