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We note that both devices may be used in the outpatient setting, as such, we do not believe that the surgical approach or healthcare setting distinguishes the aprevo Cervical ACDF System from the aprevo (IFD) for purposes of the device category code assignment

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This timeframe is dictated by USP (United States Pharmacopeia) standards for sterile preparations

GHK-Cu is a naturally occurring tripeptide found in human plasma, saliva, and urine