TOTAL SHOULDER REPLACEMENT - HUMERAL STEM WITH HEAD - India CDSCO Medical Device Registration

TOTAL SHOULDER REPLACEMENT - HUMERAL STEM WITH HEAD is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID MFG/MD/2019/000196_f0ef8458dd2480448501fcf6d2ec82f8_d253ef8130c240a307b0cd5aa22a8be6. 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 SHOULDER REPLACEMENT - HUMERAL STEM WITH HEAD

UID: MFG/MD/2019/000196_f0ef8458dd2480448501fcf6d2ec82f8_d253ef8130c240a307b0cd5aa22a8be6

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

PRODUCT IS INDICATED FOR USE IN SHOULDERARTHROPLASTY FOR REDUCTION OR RELIEF OF PAIN AND/OR IMPROVED SHOULDER FUNCTION IN SKELETALLY MATURE PATIENTS WITH ENOUGH AND SATISFACTORY BONE STOCK TO SUPPORT THE PROSTHESIS WITH THE FOLLOWING CONDITIONS: A. NON-INFLAMMATORY DEGENERATIVE JOINT DISEASE INCLUDING OSTEOARTHRITIS AND A VASCULAR NECROSIS. B. RHEUMATOID ARTHRITIS. C. REVISION WHERE OTHER DEVICES OR TREATMENTS HAVE FAILED. D. CORRECTION OF FUNCTIONAL DEFORMITY. E. FRACTURES OF THE PROXIMAL HUMERUS, WHERE OTHER METHODS OF TREATMENT ARE DEEMED INADEQUATE. F. DIFFICULT CLINICAL MANAGEMENT PROBLEMS, INCLUDING CUFF ARTHROPATHY, WHERE OTHER METHODS OF TREATMENT MAYNOT BE SUITABLE OR MAY BE INADEQUATE