Amplitude Surgical, based in Valence, France, has received 510(k) approval from the US Food and Drug Administration to market its Anatomic implant that addresses degenerative knee disorders.
“Our Anatomic knee has been a real success, with more than 20,000 surgeries carried out to date. This approval provides us with access to the US market, worth over 4 billion dollars. It illustrates the high quality of our implant, which is unquestionably suited to American standards, and will enable our US subsidiary, Amplitude Orthopedics Corp., to launch its commercial activity,” says Amplitude Surgical Chairman and CEO Olivier Jallabert, in a media release.
For more information, visit Amplitude Surgical.
[Source(s): Amplitude Surgical, Business Wire]