This message was posted by a user wishing to remain anonymous
Hello,
My employer (Company A) is considering seeking 510k clearance to market a "hybrid" knee implant system in which 3 out of the 4 components are provided by another implant manufacturer (Company B), and the fourth component is developed and manufactured by Company A. Company B would provide the necessary permission to Company A to market their implant components in this manner. In this scenario would the product labels (outer packaging, IFU insert, marking on implants) for the implant components from Company B need to be relabeled for Company A? Or could the product labeling on the implant components from Company B remain as-is?
Thank you!