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To grasp the clinical significance of this complex association, it is therefore necessary to review studies directly aimed at understanding it

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Comment: In response to our concerns that all components or parts of the aprevo Cervical ACDF System may not be integral parts of the service furnished because it is unclear how and when these components or parts are used and whether they can be substituted with other products, the applicant commented that the aprevo insertion instrument, integrated fixation screws, and the CAM components are all part of the 510(k) cleared aprevo Cervical ACDF System's kit, are integral to the implant and arthrodesis services furnished, and are not supplies that are incident to the procedure

Because tolerability has not been quantified in humans, there is no evidence-based safe concentration or frequency to point to

The TGA also says it cannot chase every breach

Consistency matters more than timing for most individuals