510(k) K253507

Packaged Assembly, Reusable Navigation Unit; Lantern ASC, Smart Pack kit, Knee by Orthalign, Inc. — Product Code ONN

K253507 is an FDA 510(k) premarket notification submitted by Orthalign, Inc. for the device "Packaged Assembly, Reusable Navigation Unit; Lantern ASC, Smart Pack kit, Knee". The FDA issued a decision of Substantially Equivalent on June 2, 2026. The device falls under product code ONN (Intraoperative Orthopedic Joint Assessment Aid), a Class II device regulated under 21 CFR 882.4560. Orthalign, Inc. has at least 10 other 510(k) clearances on record.