When you read "FDA approved" don't immediately think they are talking about the USA FDA. Many other countries have analogous regulating agencies called the FDA, like thailand for example.Because i took a 5 second look at their website and immediately spotted on the bottom: "Not for sale in the USA"
Seems like a feasible alternative if CT-Bone fails to materialise, as unfortunately seems likely.All we need to know, which surgeons will be performing these implants (in the midface) within the next year?