Here are six things to know:
1. The company’s dilator used in the XLIF procedure was approved as a Class II device in Japan in 2011.
2. However, the Japanese Ministry of Health, Labour and Welfare recently announced any dilators utilized in lateral access spine procedures must be approved as Class III medical devices.
3. NuVasive resubmitted its dilator as a Class III medical device, and surgeons halted performing XLIF procedures in Japan while the reclassification pended.
4. Surgeons in Japan may once again perform XLIF procedures in the country.
5. Surgeons have treated more than 150,000 patients with the XLIF procedures, globally.
6. The XLIF procedure is a minimally invasive procedure using neuromonitoring.
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