FDA dings Spinal Elements for design changes, unreviewed claims

The FDA issues a formal warning letter to Spinal Elements, saying the company needs to seek new regulatory review for design changes and marketing claims for its spinal fusion devices.

The FDA posted a warning letter against California-based Spinal Elements, saying that the company failed to obtain regulatory clearance for design changes to certain of its intervertebral body fusion devices.

Food & Drug Administration (FDA), Spinal Elements

News Well, Food & Drug Administration (FDA), Regulatory/Compliance, Spinal, Warning Letter

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