OssDsign receives US FDA clearance for Cranial PSI Accessories – strengthening business position in the US
OssDsign AB (publ) (“OssDsign” or the “Company”) today announced that the US Food and Drug Administration (FDA) has granted 510(k) clearance (K190523) to market OssDsign Cranial PSI Accessories in the US. The cleared products are a set of 3D-printed, patient specific accessory devices designed to support and expand clinical use of OssDsign’s patient specific cranioplasty implant already cleared by the FDA. The accessories are designed to make cranial reconstructions safer and easier and to enable new solutions for patients in need of complex cranial reconstructions.OssDsign is a provider of