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Tag: 510(k)

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Need to Know

BMJ Studies Address Safety of Devices and Alendronate

July 5, 2016 OrthoBuzz for Surgeons

BMJ recently published two studies of interest to orthopaedists: After analyzing data from more than 200 cardiovascular, orthopaedic, and neurologic devices approved in both the

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Need to Know

Lots of Ortho Device Recalls with 510(k) Process

March 31, 2016 OrthoBuzz for Surgeons

Most orthopaedic devices are cleared through the FDA’s 510(k) process. But an analysis in the March 16, 2016 JBJS by Day et al. revealed that

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