510(k) K163383

GREENS BRAND Locking Bone Plates and Screws Osteosynthesis Plating System, GREENS BRAND Of DHS/Dynamic Condylar Plate Plating System by Greens Surgicals Pvt. , Ltd. — Product Code HRS

K163383 is an FDA 510(k) premarket notification submitted by Greens Surgicals Pvt. , Ltd. for the device "GREENS BRAND Locking Bone Plates and Screws Osteosynthesis Plating System, GREENS BRAND Of DHS/Dynamic Condylar Plate Plating System". The FDA issued a decision of Substantially Equivalent on April 19, 2017. The device falls under product code HRS (Plate, Fixation, Bone), a Class II device regulated under 21 CFR 888.3030. Greens Surgicals Pvt. , Ltd. has at least 1 other 510(k) clearance on record.