OssDsign AB – FDA 483

This document is a Q-Submission from Weissburg Associates on behalf of OssDsign AB concerning their OSSDIGN Cranial PSI (K161090), which is currently on an FDA hold. The submission requests guidance and clarification on several deficiencies identified by the FDA in a previous letter. OssDsign AB also requests that the submission and subsequent communications be held in confidence by the FDA, as per 21 CFR 807.95.