LDR Spine, a total spine solution company, announced today that it obtained approval for an Investigational Device Exemption (IDE) from the United States Food and Drug Administration (FDA). This allows the company to conduct a pivotal human clinical trial to investigate the safety and effectiveness of the Mobi-C(R) cervical artificial disc. This is the only active one and two-level clinical trial approved by the FDA for an artificial cervical disc and the first FDA-approved study of a second-generation cervical disc device.
