LARS ACJ— 510(k) K253115

Name: FDA 510(k) clearance K253115
Creator: U.S. Food and Drug Administration
Published: 2026-06-10

Substantially Equivalent

Movmedix S.A.S.

FDA 510(k) clearance K253115 for LARS ACJ, Substantially Equivalent on 2026-06-10. Applicant: Movmedix S.A.S.. Device class: 2.

Summary

Movmedix's LARS ACJ is filed under HTN, bolt nut washers. The record doesn't expand "LARS" or "ACJ" or describe the product further.

Class II, 21 CFR 888.3030. Orthopedic is both the classification panel and the review panel. It was a Traditional 510(k).

Movmedix filed from Arc-Sur-Tille, France. Review took 259 calendar days (September 24, 2025 to June 10, 2026).

Clearance details

Applicant: Movmedix S.A.S.
Product code: Product code HTN
Device class: Class 2
Regulation: 21 CFR 888.3030
Advisory panel: Orthopedic
Date received: 2025-09-24
Decision date: 2026-06-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Arc-Sur-Tille, FR

Download summary PDF View on FDA.gov ↗

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Adverse events under product code HTN

product code HTN

Injury: 310
Malfunction: 639
Total: 949

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.