CDSCO UID IMP/MD/2018/000346_c4fb0b40bf18fba976c8639945ef0dbf_8f0484932e1511cfd58a7f3d4f3162a6
Shoulder System- Stem
Johnson & Johnson Private Limited·Device Class Class D·India CDSCO·Brand: Corail
Registration details
- UID
- IMP/MD/2018/000346_c4fb0b40bf18fba976c8639945ef0dbf_8f0484932e1511cfd58a7f3d4f3162a6
- Device class
- Class D
- Brand name
- Corail
- License holder
- Johnson & Johnson Private Limited
- Approving authority
- CDSCO
- Product information
- The GLOBAL UNITE Platform Shoulder System is intended for cemented or uncemented total or hemishoulder arthroplasty in treatment of the following: • A severely painful and/or disabled joint resulting from osteoarthritis, traumatic arthritis or rheumatoid arthritis • Fracture of the proximal humerus where the articular surface is severely comminuted, separated from its blood supply or where the surgeon’s experience indicates that alternative methods of treatment are unsatisfactory • Irreducible 3- and 4-part fractures of the proximal humerus • Ununited humeral head fractures • Avascular necrosis of the humeral head • Other difficult clinical problems where shoulder arthrodesis or resection arthroplasty are not acceptable (Corail) Hemi-shoulder arthroplasty is also indicated for: • Deformity and/or limited motion GLOBAL UNITE Humeral Stems, in conjunction with existing DELTA XTEND™ Epiphyseal Components, are indicated for use in reverse shoulder arthroplasty in treatment of a grossly deficient rotator cuff joint with severe arthropathy or a previously failed joint replacement with a grossly deficient rotator cuff joint. The patient’s joint must be anatomically and structurally suited to receive the selected implant(Corail), and a functional deltoid muscle is necessary to use the device. When used in a total shoulder arthroplasty, the GLOBAL UNITE Implants are to be used with DePuy glenoid components. The glenoid components are for cemented use only. GLOBAL UNITE Humeral Implants are for cemented or uncemented use
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About this record
Shoulder System- Stem is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2018/000346_c4fb0b40bf18fba976c8639945ef0dbf_8f0484932e1511cfd58a7f3d4f3162a6. This device is marketed under the brand name Corail. The license holder is Johnson & Johnson Private Limited, and it is classified as Device Class Class D. The approving authority is CDSCO.
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