Lantern Knee Navigation Unit (406000-03); Lantern Hip Navigation Unit (502000-03)— 510(k) K262253
Substantially EquivalentOrthalign, Inc.
FDA 510(k) clearance K262253 for Lantern Knee Navigation Unit (406000-03); Lantern Hip Navigation Unit (502000-03), Substantially Equivalent on 2026-07-31. Applicant: Orthalign, Inc.. Device class: 2.
Summary
Orthalign's clearance covers the Lantern Knee Navigation Unit (406000-03) and the Lantern Hip Navigation Unit (502000-03), filed under ONN, intraoperative orthopedic joint assessment aids. The record doesn't describe what the units measure.
Class II, 21 CFR 882.4560. The Orthopedic review panel handled it as a Special 510(k), though the record lists Neurology as the classification panel.
Orthalign filed from Irvine, California. The decision came 29 calendar days after FDA received it (July 2 to July 31, 2026).
Clearance details
- Device name as filed
- Lantern Knee Navigation Unit (406000-03);Lantern Hip Navigation Unit (502000-03)
- Applicant
- Orthalign, Inc.
- Product code
- Product code ONN
- Device class
- Class 2
- Regulation
- 21 CFR 882.4560
- Advisory panel
- Neurology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Irvine, CA, US
Recent devices under product code ONN
view allMore clearances from Orthalign, Inc.
view allData sourced from openFDA. This site is unofficial and independent of the FDA.