KLS Martin Individual Patient Solutions

About This 510(k) Submission

K180962 is an FDA 510(k) clearance for the KLS Martin Individual Patient Solutions, a Plate, Bone (Class II — Special Controls, product code JEY), submitted by KLS-Martin L.P. (Jacksonville, US). The FDA issued a Cleared decision on August 13, 2018, 123 days after receiving the submission on April 12, 2018. This device falls under the Dental review panel. Regulated under 21 CFR 872.4760.