510(k) K213982

Pacific Instruments Orthopedic Fixation Pins and Wires / Kirschner / Guide Wires by Pacific Instruments — Product Code HTY

K213982 is an FDA 510(k) premarket notification submitted by Pacific Instruments for the device "Pacific Instruments Orthopedic Fixation Pins and Wires / Kirschner / Guide Wires". The FDA issued a decision of Substantially Equivalent on February 17, 2022. The device falls under product code HTY (Pin, Fixation, Smooth), a Class II device regulated under 21 CFR 888.3040.