https://www.fda.gov/medical-devices/premarket-notification-510k/c...

https://www.fda.gov/medical-devices/premarket-notification-510k/content-510k

For example.. Its not like its gone to the CBER or down an intense biologics licencing application as a polymer implant, but yes will have had to show some efficacy in the process, or had to show equivalency if done on a comparable basis to existing products in market, "A 510(k) requires demonstration of substantial equivalence to another legally U.S. marketed device. Substantial equivalence means that the new device is as safe and effective as the predicate. the information submitted to FDA demonstrates that the device is as safe and effective as the legally marketed device" or more stringent requirements if a new device to market. OSteopre showed equivalency:

https://www.accessdata.fda.gov/cdrh_docs/pdf5/K051093.pdf

"CE marking is the medical device manufacturer's claim that a product meets the General Safety and Performance Requirements (GSPR) of all relevant European Medical Device Regulations and is a legal requirement to place a device on the market in the European Union."

There are similar CE equivalancy or performance evidence requirements. TGA approval, Singaporean approval similar. The main bodies of evience OSX has used per its website:

https://www.osteopore.com/osteopore-technology

(go to footnotes on efficacy data)

For example:

https://pubmed.ncbi.nlm.nih.gov/33613837/

I think OSX could be doing a far better job of explaining all this, if I seem some sort of company advocate - they are a bit crap at communcating this stuff IMO - its all a bit connect the dots that investors should be able to do far easier by provision of clear protocols and evidence that got them approved in the various lcoations.

https://osteopore.com/sites/default/files/osteopore-academy/WP-Septal-Extension-Graft-Augmentation-with-Osteomesh-%28MCN-03-007W-AL-Rev-3_060122%29.pdf