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A., Hayreh M

Once oxygen levels return to normal, the hypoxic response turns off, and cellular processes resume

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