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Based on the information provided in the comment and our review of the application, we agree with the applicant that the aprevo Cervical ACDF System meets the criterion because the referenced components are only intended to be used with the aprevo Cervical ACDF System, commercially available insertion instruments or screws cannot be utilized with the device, and the use of these components is necessary and/or required to furnish or deliver the primary procedure(s) with which it is used, and are not supplies incident to the procedure

Indications for use - polyneuropathy of various origins - neuritis and neuralgia - radiculoneuritis due to degenerative diseases of the spine (cervical syndrome, hand and forearm cider, lumbar syndrome) - sciatica - trigeminal neuralgia, intercostal neuralgia Method of administration and dosage The drug is injected only intramuscularly (in the upper outer quadrant of the gluteus maximus muscle)

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