510(k) K222282

HEMC BRAND Locking Bone Plates and Screws Osteosynthesis Plating System by Hospital Equipment Manufacturing Company — Product Code HRS

K222282 is an FDA 510(k) premarket notification submitted by Hospital Equipment Manufacturing Company for the device "HEMC BRAND Locking Bone Plates and Screws Osteosynthesis Plating System". The FDA issued a decision of Substantially Equivalent on Oct 27, 2022. The device falls under product code HRS (Plate, Fixation, Bone), a Class II device regulated under 21 CFR 888.3030.