LARS ACJ— 510(k) K253115

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..

Clearance details

Applicant: Movmedix S.A.S.
Product code: Code HTN
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 ↗

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.