Restoration GAP systems - India CDSCO Medical Device Registration

Restoration GAP systems is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2020/000112_931d68c26cf9815a234bf12887cb7583_1bdec15eef20628652d2e6de838a6b78. This device is marketed under the brand name Total Knee Replacement. The license holder is Stryker India Pvt. Ltd.,, and it is classified as Device Class Class C. The approving authority is CDSCO.

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CDSCO Registered

Class Class C

Restoration GAP systems

UID: IMP/MD/2020/000112_931d68c26cf9815a234bf12887cb7583_1bdec15eef20628652d2e6de838a6b78

Brand Name

Total Knee Replacement

License Holder

Stryker India Pvt. Ltd.,

Device Class

Class C

Approving Authority

CDSCO

Product Information

It is indicated in painful ,disabling joint disease of the hip resulting from degenerative arthritis , rheumatoid arthritis , post-traumatic arthritis or late stage avascular necrosis, revision of previous unsuccessful femoral head replacement ,cup arthroplasty or other procedures , clinical management problems where arthrodesis or alternative reconstructive techniques are less likely to achieve satisfactory results , where bone stock is of poor quality or inadequate for other reconstructive techniques as indicated by deficiencies of the acetabulum, segmental and/ or cavitary acetabular defects which make it difficult to restore normal hip biomechanics or to reconstitute the normal structural continuity and integrity of the acetabulum ,using standard total hip replacement acetabular components and procedures

Class C

Tibial Trays/Baseplate

Brand: Total Knee Replacement

Stryker India Pvt. Ltd.,

Class C

Brand: Ideal Eyes

Class B

Endoscopic Cameras and Image Processors

Class B

Urology and Gynecology Systems

Class B