CDSCO UID MFG/MD/2019/000196_49fc1e770716429c1dd87b38415dde82_e4bc572515d656fb76d25c976e7f9836
TOTAL KNEE REPLACEMENT - TIBIAL & FEMORAL 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_49fc1e770716429c1dd87b38415dde82_e4bc572515d656fb76d25c976e7f9836
- 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 INTENDED TO 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 YOUNGER PATIENTS IF, IN THE OPINION OF THE SURGEON, AN UNEQUIVOCAL INDICATION FOR TKR OUTWEIGHS THE RISKS ASSOCIATED WITH THE AGE OF THE PATIENT, AND IF LIMITED DEMANDS REGARDING ACTIVITY AND KNEE JOINT LOADING CAN BE ASSURED. THIS INCLUDES SEVERELY CRIPPLED PATIENTS WITH MULTIPLE JOINT INVOLVEMENT FOR WHOM AGAIN IN KNEE MOBILITY MAY LEAD TO AN EXPECTATION OF SIGNIFICANT IMPROVEMENT IN THE QUALITY OF THEIR LIVES. TKR IS INDICATED FOR A SEVERELY PAINFUL AND/OR DISABLED JOINT FROM OSTEOARTHRITIS, POST-TRAUMATIC ARTHRITIS, RHEUMATOID ARTHRITIS OR A FAILED PREVIOUS IMPLANT
Similar products (10)
Other products with the same name or brand
TOTAL HIP REPLACEMENT - ACETABULAR CUP, FEMORAL STEM
Brand: SHARMA, SPCPL, DKSORTHO, DKSORTHO MEDICAL DEVICES
M/s Emporis Implants And Surface Treatment
Class D
SPINAL IMPLANTS
Brand: SHARMA, SPCPL, DKSORTHO, DKSORTHO MEDICAL DEVICES
DKSORTHO & SHARMA PHARMACEUTICAL PRIVATE LIMITED
Class C
BONE SCREWS
Brand: SHARMA, SPCPL, DKSORTHO, DKSORTHO MEDICAL DEVICES
DKSORTHO & SHARMA PHARMACEUTICAL PRIVATE LIMITED
Class C
TOTAL SHOULDER REPLACEMENT - HUMERAL STEM WITH HEAD
Brand: SHARMA, SPCPL, DKSORTHO, DKSORTHO MEDICAL DEVICES
DKSORTHO & SHARMA PHARMACEUTICAL PRIVATE LIMITED
Class C
TOTAL SHOULDER REPLACEMENT - HUMERAL STEM WITH HEAD
Brand: SHARMA, SPCPL, DKSORTHO, DKSORTHO MEDICAL DEVICES
DKSORTHO & SHARMA PHARMACEUTICAL PRIVATE LIMITED
Class C
BONE NAILS
Brand: SHARMA, SPCPL, DKSORTHO, DKSORTHO MEDICAL DEVICES
DKSORTHO & SHARMA PHARMACEUTICAL PRIVATE LIMITED
Class C
ORAL MAXILLOFACIAL IMPLANTS
Brand: SHARMA, SPCPL, DKSORTHO, DKSORTHO MEDICAL DEVICES
DKSORTHO & SHARMA PHARMACEUTICAL PRIVATE LIMITED
Class C
TOTAL KNEE REPLACEMENT - PATELLAR & TIBIAL TRAY COMPONENT
Brand: SHARMA, SPCPL, DKSORTHO, DKSORTHO MEDICAL DEVICES
DKSORTHO & SHARMA PHARMACEUTICAL PRIVATE LIMITED
Class C
BONE PINS & WIRES
Brand: SHARMA, SPCPL, DKSORTHO, DKSORTHO MEDICAL DEVICES
DKSORTHO & SHARMA PHARMACEUTICAL PRIVATE LIMITED
Class C
BONE PLATES
Brand: SHARMA, SPCPL, DKSORTHO, DKSORTHO MEDICAL DEVICES
DKSORTHO & SHARMA PHARMACEUTICAL PRIVATE LIMITED
Class C
Other products from DKSORTHO & SHARMA PHARMACEUTICAL PRIVATE LIMITED
Products from the same license holder (10 products)
TOTAL KNEE REPLACEMENT INSTRUMENT SET
Brand: DKSORTHO,SHARMA,SPCPL
Class B
TOTAL HIP REPLACEMENT INSTRUMENT SET
Brand: DKSORTHO,SHARMA,SPCPL
Class B
External Ring Fixation System
Brand: DKSORTHO,SHARMA,SPCPL
Class B
SPINE INSTRUMENT SET
Brand: DKSORTHO,SHARMA,SPCPL
Class B
Plating System Instrument Set
Brand: DKSORTHO,SHARMA,SPCPL
Class B
Intramedullary Locking Nails Instrument Sets
Brand: DKSORTHO,SHARMA,SPCPL
Class B
SPINAL IMPLANTS
Brand: SHARMA, SPCPL, DKSORTHO, DKSORTHO MEDICAL DEVICES
Class C
BONE SCREWS
Brand: SHARMA, SPCPL, DKSORTHO, DKSORTHO MEDICAL DEVICES
Class C
TOTAL SHOULDER REPLACEMENT - HUMERAL STEM WITH HEAD
Brand: SHARMA, SPCPL, DKSORTHO, DKSORTHO MEDICAL DEVICES
Class C
TOTAL SHOULDER REPLACEMENT - HUMERAL STEM WITH HEAD
Brand: SHARMA, SPCPL, DKSORTHO, DKSORTHO MEDICAL DEVICES
Class C
About this record
TOTAL KNEE REPLACEMENT - TIBIAL & FEMORAL COMPONENT is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID MFG/MD/2019/000196_49fc1e770716429c1dd87b38415dde82_e4bc572515d656fb76d25c976e7f9836. 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.
This page provides comprehensive regulatory information including complete registration details, license holder information, device classification, and related products. Pure Global AI offers free access to 71,807+ India medical device registrations, helping global MedTech companies identify partners, analyze markets, and discover business opportunities efficiently.