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CDSCO UID MFG/MD/2019/000196_f0ef8458dd2480448501fcf6d2ec82f8_be63ccf9aee291589de9749a1610e2fa

TOTAL SHOULDER REPLACEMENT - HUMERAL STEM WITH HEAD

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_f0ef8458dd2480448501fcf6d2ec82f8_be63ccf9aee291589de9749a1610e2fa
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
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.
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About this record

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_be63ccf9aee291589de9749a1610e2fa. 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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