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/2021/000137_028fbd80c4bec598aefa8dfc359138a4_15233ce54b1f813c32a908205918d7c0. This device is marketed under the brand name BOND+WELL. The license holder is BOND+WELL ORTHO PRODUCTS, 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/2021/000137_028fbd80c4bec598aefa8dfc359138a4_15233ce54b1f813c32a908205918d7c0

Brand Name

BOND+WELL

License Holder

BOND+WELL ORTHO PRODUCTS

Device Class

Class C

Approving Authority

Central Drug Standards Control Organization, Ahmedabad

Product Information

The Intra Medullary 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.Intra Medullary Nail 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