FDA warns Allez Spine over design revisions to spinal screw

10/22/2008 | FDAnews

The FDA has issued a warning letter to Allez Spine saying that the firm made modifications to its Laguna Pedicle Screw System without filing a premarket application. Allez said it intends to introduce an updated version of the spinal fixation device and submit it to the agency for 510(k) clearance.

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