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FDA PRODUCT CODE · CLASS II

ONN — Intraoperative Orthopedic Joint Assessment Aid

Measurement and interpretation of orthopedic joint information.

DEVICE CLASS
Class II
REGULATION
21 CFR 882.4560
MEDICAL SPECIALTY
Neurology
REVIEW PANEL
OR
— Implant— Life-sustaining— GMP-exempt— Third-party review eligible
4
510(K)/PMA CLEARANCES
510k: 4
0
RECALL ENTRIES

Recent clearances

K253507Orthalign, Inc. · 510k2026-06-02
K252524Eventum Orthopaedics, Ltd. · 510k2025-09-09
K241298Eventum Orthopaedics, Ltd. · 510k2024-10-04
K242616Orthalign, Inc. · 510k2024-10-03

Related on SPEQ

Medical devices industry →Medical device quality (ISO 13485) →FDA device clearances →FDA enforcement & recalls →

Source: FDA device classification, 510(k)/PMA, and recall datasets (openFDA). Recall entries count distinct FDA recall numbers, so one recall event affecting several products appears as several entries. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data.

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