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The EBI® Distal Radius Plating System is indicated for the fixation of fractures and osteotomies involving the distal radius.

The EBI® Distal Radius Plating System is intended to provide fixation of fractures and osteotomies involving the distal radius. The System is comprised of an array of plates and screws, which will provide fixation of the distal radius.

The provided text is a 510(k) Summary for the EBI® Distal Radius Plating System and the FDA's clearance letter. However, it does not contain any information about acceptance criteria, device performance testing, or study results.

The 510(k) submission process primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than requiring extensive clinical trials or performance studies with acceptance criteria in the same way a PMA (Pre-Market Approval) submission would.

Therefore, I cannot provide the requested information from the given text. The document states:

"There are no significant differences between the EBI® Distal Radius Plating System and other currently marketed internal fixation systems. It is substantially equivalent to the predicate device in regards to intended use, materials, and function."

This indicates that the device's clearance was based on its similarity to existing devices, not on a new study that proves it meets specific performance acceptance criteria.

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