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Legal, Clinical & Regulatory

FDA 510(k) Highlights: Five Companies Gain First Orthopaedic Clearances

To provide insight on new competitors entering the U.S. orthopaedic market, we offer details on five companies and their first orthopaedic FDA 510(k) clearances.

Why the Inadvertent Release of Non-Conforming Products is Reportable, Recordable

It is recommended to err on the side of caution in these situations and report the product release, as well as record any internal corrections.

Protecting Your Design with Patents

A smart legal strategy is to develop a comprehensive intellectual property portfolio of the various diverse—but related—IP rights associated with the inventive device.