LDR has announced it has received FDA conditional approval for its Mobi-C cervical disc, according to a news release.
LDR describes Mobi-C as a metal and polyethylene mobile bearing prosthesis designed as a low-profile cervical intervertebral disc replacement for both one and two level applications.
"We are pleased that the FDA, after an intensive review of our submission for Mobi-C, has determined it to be approvable based on the strength of the data provided in the premarket approval application. We are confident that we can efficiently complete the remaining requirements inherent in the full approval process and we anticipate commercial U.S. availability of Mobi-C in 2013," said Christophe Lavigne, president and CEO of LDR, in the release. "Given the high incidence of two-level cervical disease, we are proud that Mobi-C may become the first cervical disc available to treat patients on-label that suffer from two-level pathology."
LDR is headquartered in Austin, Texas.
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