Our notified body is asking for PMCF studies with sufficient enrollment to evaluate all product variants. I don't think they have considered what that entails for a spinal implant. Has anyone had a similar question. It makes sense on the surface, until you do the math. For example, our anterior cervical plate has 41 different sizes, times 15 different screw sizes times enrollment of say 20 patients, comes to 12,300 patients. I guess you could do a DOE, but I never heard of a DOE PMCF study. This is actually one of our simpler systems. For one of our stand-alone interbodies, enrollment could be in the 100,000 or more. I just find it hard to believe this same question is being posed to other manufacturers of spinal implants.