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CDSCO UID MFG/MD/2023/000077_70096ae85245e535caaf0d802f555c4a_327c8d4aa820e1fb3fbf955ff3bdc4fd

TOTAL KNEE REPLACEMENT SYSTEM

BOMBAY ORTHO INDUSTRIES PRIVATE LIMITED·Device Class Class C·India CDSCO·Brand: ACTIKNEE, NEXWAY, KNEEWISE
Registration details
UID
MFG/MD/2023/000077_70096ae85245e535caaf0d802f555c4a_327c8d4aa820e1fb3fbf955ff3bdc4fd
Device class
Class C
Brand name
ACTIKNEE, NEXWAY, KNEEWISE
License holder
BOMBAY ORTHO INDUSTRIES PRIVATE LIMITED
Approving authority
Central Drug Standards Control Organization, Ahmedabad
Product information
The Total Knee System is indicated for replacement of knee or knee components for patients suffer from severe knee pain and disability due to: • Degenerative knee joint disease: rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis; • Correction of functional deformities; • Post-traumatic loss of knee joint contour; • Moderate valgus, varus, or flexion trauma; • Knee fractures untreatable by other methods.
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About this record

TOTAL KNEE REPLACEMENT SYSTEM is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID MFG/MD/2023/000077_70096ae85245e535caaf0d802f555c4a_327c8d4aa820e1fb3fbf955ff3bdc4fd. This device is marketed under the brand name ACTIKNEE, NEXWAY, KNEEWISE. The license holder is BOMBAY ORTHO INDUSTRIES 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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