FDA inspectors warn NuVasive on marketing for Affix spinal implants

March 19, 2013 by Arezu Sarvestani

NuVasive explains that an FDA Warning Letter following an inspection at a California manufacturing facility reflects only an issue with marketing – not with any quality systems.

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Federal regulators warned NuVasive (NSDQ:NUVA) this month about certain promotional claims made in connection with the company's spinal products.

The FDA in October 2012 inspected NuVasive's San Diego, Calif., manufacturing facility, finding only the single violation regarding marketing language for the company's Affix Spinous Process Plate System.

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NuVasive had marketed the Affix devices "as an adjunct to interbody fusion (XLIF®, ALIF, PLIF, and TLIF.)," according to the FDA inspection report.

"Although your firm has multiple 510(k)s cleared for this device, none of them include the use of the Affix plate with only an intervertebral body fusion device," the inspectors said. "This constitutes a new intended use and a new 510(k) is required."

NuVasive updated shareholders on the warning letter, noting that the violations relate only to language about the Affix device and that there were no issues with manufacturing at the facility.

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