Unic Shoulder Prothesis - India CDSCO Medical Device Registration
Unic Shoulder Prothesis is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2020/000543_5626851dd65dfa2a26b5388029a27d25_6de734b04a3d0ff3e1d2b4c7ff8cae4d. The license holder is EVOLUTIS INDIA PVT. LTD., and it is classified as Device Class Class C. The approving authority is CDSCO.
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License Holder
EVOLUTIS INDIA PVT. LTD.Device Class
Approving Authority
CDSCO
Product Information
Hemi and total anatomic shoulder arthroplasty are indicated for the treatment of symptomatic pain and/or functional problems of the shoulder in patients whose skeleton is mature and only when pain killers and conservative treatment used correctly have failed. The anatomy and structure of the patient’s articulation will need to be adapted to receive the selected implant(NA). The indications for total anatomic or partial shoulder arthroplasty are: -Degenerative non -inflammatory arthropathy: centered shoulder arthritis, osteonecrosis of the humeral head. -Inflammatory arthropathy such as rheumatoid arthritis, or post traumatic arthritis. -Post Traumatic degenerative arthritis. -Functional repair of recent complex proximal humeral fractures at the elderly. -Revision of a previous failed partial or total arthroplasty. Whatever is the pathology the presence of a functional or repairable rotator cuff is absolutely necessary for the establishment of an indication of partial or total anatomic shoulder arthroplasty
