510(k) K202105

OsteoMed ExtremiFix Mini & Small System Tray by Osteomed, LLC — Product Code KCT

K202105 is an FDA 510(k) premarket notification submitted by Osteomed, LLC for the device "OsteoMed ExtremiFix Mini & Small System Tray". The FDA issued a decision of Substantially Equivalent on October 29, 2020. The device falls under product code KCT (Sterilization Wrap Containers, Trays, Cassettes & Other Accessories), a Class II device regulated under 21 CFR 880.6850. Osteomed, LLC has at least 10 other 510(k) clearances on record.