CUVIS-joint (CJ150)— 510(k) K252037

Name: FDA 510(k) clearance K252037
Creator: U.S. Food and Drug Administration
Published: 2026-03-25

Substantially Equivalent

Curexo, Inc.

FDA 510(k) clearance K252037 for CUVIS-joint (CJ150), Substantially Equivalent on 2026-03-25. Applicant: Curexo, Inc.. Device class: 2.

Summary

Curexo's CUVIS-joint (CJ150) is filed under OLO, orthopedic stereotaxic instruments. The record doesn't describe the system beyond its name and that code name.

Class II, 21 CFR 882.4560. The Orthopedic review panel handled it as a Traditional 510(k), though the record lists Neurology as the classification panel.

Curexo filed from Seoul, South Korea. The decision came 268 calendar days after receipt (June 30, 2025 to March 25, 2026).

Clearance details

Applicant: Curexo, Inc.
Product code: Product code OLO
Device class: Class 2
Regulation: 21 CFR 882.4560
Advisory panel: Neurology
Date received: 2025-06-30
Decision date: 2026-03-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Seoul, KR

Download summary PDF View on FDA.gov ↗

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Adverse events under product code OLO

product code OLO

Death: 11
Injury: 2,799
Malfunction: 11,105
Other: 1
Total: 13,916

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.