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In contrast to the placebo-treated subjects who experienced minimal changes in body weight over the 16-week treatment period, the pramlintide-treated subjects attained significant weight loss from baseline as early as week 2, which was progressive up to week 16, with no evidence of a plateau

We noted that the aprevo Cervical ACDF-X system ( (with and without CAM) includes additional components, such as the integrated fixation screws, and has a different indicated use as stated in the November 15, 2024, FDA 510(k) clearance letter (K242260)