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FDA granted the applicant 510(k) clearance for the aprevo Cervical ACDF System on November 15, 2024, with separate indications for the aprevo Cervical ACDF system and the aprevo Cervical ACDF-X system (with and without CAM)

A compound can be widely discussed and still rest almost entirely on cell-culture and animal data, with little or no controlled human evidence

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However, the research was done in rats, so more human studies are necessary to confirm this potential benefit