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Orthopedic Intramedullary Nails - Titanium - India CDSCO Medical Device Registration

Orthopedic Intramedullary Nails - Titanium is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID MFG/MD/2021/000347_dd70d2451979ae0371e531b018b0f0fa_7e6ac62cc18bf3b0e271ce76e0dc6aa5. This device is marketed under the brand name CARE, ACE, FRAGMENT, AOCARE, AIMEN. The license holder is Ortho Care, and it is classified as Device Class Class C. The approving authority is CDSCO -North Zone, Ghaziabad.

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CDSCO Registered
Class Class C
Orthopedic Intramedullary Nails - Titanium
UID: MFG/MD/2021/000347_dd70d2451979ae0371e531b018b0f0fa_7e6ac62cc18bf3b0e271ce76e0dc6aa5

Brand Name

CARE, ACE, FRAGMENT, AOCARE, AIMEN

License Holder

Ortho Care

Device Class

Class C

Approving Authority

CDSCO -North Zone, Ghaziabad

Product Information

Tibial Nails: The ORTHO CARE Tibial Nail is intended to stabilize fractures of the proximal and distal tibia and the tibial shaft; open and closed tibial shaft fractures; certain pre- and post-isthmic fractures; and tibial malunions and non-unions. The tibial nails can be of Interlocking tibial nail, cannulated tibial nail and distal tip distal locking tibial nail types. Un-reamed Femoral Nails: The ORTHO CARE Retrograde/Antegrade Femoral Nail System is intended to stabilize fractures of the distal femur and the femoral shaft, including supracondylar fractures, including those with intra-articular extension; ipsilateral hip/shaft fractures; ipsilateral femur/tibia fractures; femoral fractures in multiple trauma patients; fractures proximal to total knee arthroplasty; fractures distal to a hip implant; fractures in the morbidly obese; fractures in osteoporotic bone, impending pathologic fractures; and malunions and nonunions. Universal Femoral Nails: The ORTHO CARE femoral nail is indicated for use in a variety of femoral fractures such as Comminuted fractures, Segmental fractures, Fractures with bone loss, Proximal and distal fractures, Nonunions, Subtrochanteric fractures, Intertrochanteric fractures. Supracondylar Nails: The ORTHO CAREsupracondylar intramedullary nails are intended for use in fixation of various types of fractures of supracondylar or distal region of the femur as well as for proximal fractures in conjunction with supracondylar fractures. Proximal Femoral Nail, Proximal Femoral Nail-Long: The ORTHO CARE proximal femoral nail is intended to treat stable and unstable proximal femoral fractures including pertrochanteric fractures, intertrochanteric fractures, high subtrochanteric fractures. Cannulated Humeral Nails: The ORTHO CARE Cannulated Humeral Nail System is intended to aid in the alignment and stabilization of humeral fractures to include Diaphyseal fractures of the humeral shaft, Fractures of the proximal humerus, Proximal humeral fractures with diaphyseal extension, Impending pathologic fractures &Malunions and nonunions. Unreamed Humeral Nails: The ORTHO CARE unreamed humeral nails are indicated for the treatment of fractures of proximal humerus. Recon Nails: The ORTHO CARE Recon Nail System is a fracture fixation device comprised of reconstruction nails and the related accessories such as washers, locking screws, set screws, end caps, and lag screws. The devices are intended to provide strong and stable internal fracture fixation with minimal soft tissue irritation of the tibia and femur. This device is utilized as an aid to healing, not as a substitute for normal intact bone and tissue. Gamma Nail The ORTHO CARE Gamma Nail is indicated for use in fixation of femoral fractures occurring from the base of the femoral neck extending distally to a point proximal to intercondylar notch. Fracture types include basilar neck, intertrochanteric, subtrochanteric fractures and femoral shaft fractures. Elastic Nails: The ORTHO CARE Elastic Intramedullary Nail System is indicated for fixation of diaphyseal fractures where the canal is narrow or flexibility of the implant is important. This includes upper extremity fractures in all patients and lower extremity fractures in pediatric or small-stature patients. This system is also intended to treat metaphyseal and epiphyseal fractures, such as radial neck fractures and is intended for fixation of small long bones, such as carpal and tarsal bones.

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