FDA cleared the Spinalogic Bone Growth Stimulator from Djo, LLC on Sep 29, 2026 under K262721, a traditional 510(k). The device falls under product code LOF, Stimulator, Bone Growth, Non-Invasive, regulated at 21 CFR 890.5870 as a Class 2 device. The review panel was Orthopedic.
FDA logged the submission as received on Jul 31, 2026. The decision came 60 days later, inside the 90 FDA-day goal for a 510(k).
This is the only decision on file for Djo, LLC in the last 12 months of the tracker.
K262721 is the FDA 510(k) for Spinalogic Bone Growth Stimulator, submitted by Djo, LLC. FDA's decision date was Sep 29, 2026, under product code LOF (Stimulator, Bone Growth, Non-Invasive).
Djo, LLC, based in Carlsbad, CA, is the applicant of record for K262721.
FDA received the submission on Jul 31, 2026 and issued its decision on Sep 29, 2026, 60 days later.
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