TOTAL KNEE REPLACEMENT - PATELLAR & TIBIAL TRAY COMPONENT - India CDSCO Medical Device Registration

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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CDSCO Registered

Class Class C

TOTAL KNEE REPLACEMENT - PATELLAR & TIBIAL TRAY COMPONENT

UID: MFG/MD/2019/000196_a904a2a8566c8548eeb17a5b746eadea_253b84c84a1a7dc0888636aa2ee19f16

Brand Name

SHARMA, SPCPL, DKSORTHO, DKSORTHO MEDICAL DEVICES

License Holder

DKSORTHO & SHARMA PHARMACEUTICAL PRIVATE LIMITED

Device Class

Class C

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