LigaPASS System— 510(k) K261374

Substantially Equivalent

Medicrea International S.A.S

FDA 510(k) clearance K261374 for LigaPASS System, Substantially Equivalent on 2026-05-27. Applicant: Medicrea International S.A.S. Device class: 2.

Clearance details

Applicant: Medicrea International S.A.S
Product code: Code OWI
Device class: Class 2
Regulation: 21 CFR 888.3010
Advisory panel: Orthopedic
Date received: 2026-04-27
Decision date: 2026-05-27
Decision: Substantially Equivalent
Clearance type: Special
Location: Rillieux-La-Pape, FR

Download summary PDF View on FDA.gov ↗

Recent devices under product code OWI

K253615 — Invictus Bands System2026-03-25
K222097 — OLYMPIC Deformity Band System2023-05-04
K230565 — HILINE Fixation System2023-04-20
K213659 — LigaPASS 2.0 Ligament Augmentation System2022-05-24
K211057 — LigaPASS® Spinal System, CD Horizon Spinal System2021-05-27

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