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Device |
rod, fixation, intramedullary and accessories, in-vivo cured, light-activated |
Definition |
Is a device intended to be implanted that consists of a polymeric balloon that is inserted into the medullary (bone marrow) canal of long bones for the fixation of fractures. The balloon is infused with a liquid monomer that causes the balloon to fill the medullary canal of the fractured bone. The device is then exposed to a light source that polymerizes the light-activated monomer within the balloon creating a hardened rigid structure. |
Product Code | QAD |
Regulation Number |
888.3023
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Device Class |
2
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