510(k) K191793

Nebula Brand Locking Bone Plates and Screws Osteosynthesis Plating System, Nebula Brand of DHS Plating System by Nebula Surgical Private Limited — Product Code HRS

K191793 is an FDA 510(k) premarket notification submitted by Nebula Surgical Private Limited for the device "Nebula Brand Locking Bone Plates and Screws Osteosynthesis Plating System, Nebula Brand of DHS Plating System". The FDA issued a decision of Substantially Equivalent on Dec 9, 2019. The device falls under product code HRS (Plate, Fixation, Bone), a Class II device regulated under 21 CFR 888.3030.