Hip System- Revision Stem - India CDSCO Medical Device Registration

Hip System- Revision Stem is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2019/000454_5b5e477781068b689b84afcd7087d604_f8fd6cb0592c1c515a7f1beb61773d55. 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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CDSCO Registered

Class Class D

Hip System- Revision Stem

UID: IMP/MD/2019/000454_5b5e477781068b689b84afcd7087d604_f8fd6cb0592c1c515a7f1beb61773d55

Brand Name

Corail

License Holder

Johnson & Johnson Private Limited

Device Class

Class D

Approving Authority

CDSCO

Product Information

The HA-coated stem in the CORAIL Revision System is intended for use in a primary hip arthroplasty or for the revision of a failed previous hip surgery. The CORAIL Revision Stem is intended for uncemented use only. Total hip arthroplasty is intended to provide increased patient mobility and reduce pain by replacing the damaged hip joint articulation in patients where there is evidence of sufficient sound bone to seat and support the components. Total hip replacement is indicated in the following conditions: 1. A severely painful and/or disabled joint from osteoarthritis, traumatic arthritis, rheumatoid arthritis, or congenital hip dysplasia. 2. Avascular necrosis of the femoral head. 3. Acute traumatic fracture of the femoral head or neck. 4. Failed previous hip surgery including joint reconstruction, internal fixation, arthrodesis, hemiarthroplasty, surface replacement arthroplasty, or total hip replacement. 5. Certain cases of ankylosis. HA-coated stems are indicated for cementless use only

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Orthopaedic Implants- Wing

Brand: Corail

Johnson & Johnson Private Limited

Hip System- Revision Stem - India CDSCO Medical Device Registration

Brand Name

License Holder

Device Class

Approving Authority

Product Information

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