Intra-medullary nail - India CDSCO Medical Device Registration

Intra-medullary nail is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID MFG/MD/2020/000078_91bf83a94196b2295519535826080549_c8bffe27c569c058db87eb7f24dc7408. This device is marketed under the brand name Krenila. The license holder is Krenila Ortho, and it is classified as Device Class Class C. The approving authority is Central Drug Standards Control Organization, Ahmedabad.

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CDSCO Registered

Class Class C

Intra-medullary nail

UID: MFG/MD/2020/000078_91bf83a94196b2295519535826080549_c8bffe27c569c058db87eb7f24dc7408

Brand Name

Krenila

License Holder

Krenila Ortho

Device Class

Class C

Approving Authority

Central Drug Standards Control Organization, Ahmedabad

Product Information

Intra medullary Nails are used in Humerus Bone, Tibia Bone, femur bone, where found the fractures in proximal and distal area. All types of Intra medullary Nails are used inside the bone and its pass through fractures and hold the fractures with the help of Bone Screws. And its minimal insertion surgery Intra-medullary Nailing Implants are intended to be used for temporary fixation and stabilization of long bones in various anatomical regions such as proximal femur, femoral shaft, tibia and humerus. Ankle Fusion Nails are intended for tibiotalocalcaneal arthrodesis. TEN and STEN Nails are used as single implant or in pairs for Elastic Stable Intra-medullary Fixation (Krenila). Olecranon Osteotomy Nails are intended for fixation of simple fractures and osteotomies of the olecranon