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ONN

Intraoperative Orthopedic Joint Assessment Aid

Product code
ONN
Device name
Intraoperative Orthopedic Joint Assessment Aid
Device class
Class 2
21 CFR
21 CFR 882.4560
Medical specialty
Neurology
Marketing pathway
510(K)
510(k) clearances (last 3 years)
5
Summaries archived here
5 (direct download)
510(k) clearances (all years, FDA)
18 (all years; only the last 3 years are listed here)

FDA classification definition

Measurement and interpretation of orthopedic joint information.

Definition text from the FDA device classification database (U.S. federal government work, public domain).

510(k) clearances, last 3 years (5)

Last three years. Most recent: 2026-07-31.

NumberDecision dateApplicantDevice nameSummary
K2622532026-07-31Orthalign, Inc.Lantern Knee Navigation Unit (406000-03);Lantern Hip…PDF
K2535072026-06-02Orthalign, Inc.Packaged Assembly, Reusable Navigation Unit; Lantern…PDF
K2525242025-09-09Eventum Orthopaedics, Ltd.Quadsense (Quadsense and Quadsense Pro)PDF
K2412982024-10-04Eventum Orthopaedics, Ltd.QUADSENSEPDF
K2426162024-10-03Orthalign, Inc.Lantern® HipPDF

5 summaries are archived here for direct download.

Official FDA classification page: ONN
Classification and pathway per current FDA publications. Data from openFDA (CC0).