510(k) K250935

TriMed Fifth Metatarsal System (Fifth Metatarsal Plate); TriMed Fifth Metatarsal System (Fifth Metatarsal Screw) by TriMed, Inc. — Product Code HRS

K250935 is an FDA 510(k) premarket notification submitted by TriMed, Inc. for the device "TriMed Fifth Metatarsal System (Fifth Metatarsal Plate); TriMed Fifth Metatarsal System (Fifth Metatarsal Screw)". The FDA issued a decision of Substantially Equivalent on May 22, 2025. The device falls under product code HRS (Plate, Fixation, Bone), a Class II device regulated under 21 CFR 888.3030. TriMed, Inc. has at least 10 other 510(k) clearances on record.