About This 510(k) Submission
K213126 is an FDA 510(k) clearance for the Smith & Nephew, Inc. Plates and Screws Systems: EVOS, Peri-Loc, D-Rad, TC-100, VLP Mini-Mod, Compression Hip Screw (CHS), CONQUEST FN, and cannulated screws, a Device, Fixation, Proximal Femoral, Implant (Class II — Special Controls, product code JDO), submitted by Smith & Nephew, Inc. (Memphis, US). The FDA issued a Cleared decision on September 29, 2022, 367 days after receiving the submission on September 27, 2021. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3030.