FDA’s Position On Excite Spinal Products. Cites “Glaring Fallacy In Marcomms Materials”

The Freedom of Information act has come into its own with this one. A 2012 request has uncovered the fact that in direct contraditcion of its own press releases, Excite has not had Axiom FDA (510k) product approvals transferred to it, leaving such devices considered “adulterated and illegal”.

US FDA Inspection Reveals Excite Medical Does Not Own 510(k) Clearances for any DRX System (via PR Newswire)

Download image TAMPA, Fla., March 26, 2013 /PRNewswire-iReach/ — Axiom Worldwide, Inc. has verified through official correspondence from the United States Food and Drug Administration that neither Excite Medical in Tampa, Florida or HTRD Group in Hong Kong own any 510(k) clearances for any DRX system…

published: March 27, 2013 in: Regulatory, Spine

FDA’s Position On Excite Spinal Products. Cites “Glaring Fallacy In Marcomms Materials”

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