We have extensive experience authoring and compiling 510(k) submissions for submittal to the FDA. We work with accredited device testing facilities that stay up to date on the latest guidelines in order to show substantial equivalence to predicate devices. If you already have a submission, we can also provide an advisory third-party review of your submission prior to FDA submittal.

Our manufacturing partner is setup to produce low quantity prototypes as well as full production runs in PEEK, titanium and stainless steel. As needed we also source surgical instruments directly from Germany. Additionally we can coordinate production of titanium printed cages.  Alternatively, we are happy to work with your preferred manufacturers.