FDA 510(k)

LigaPASS™ System

K-Number: K261374 · 2026-05-27

Decision Date2026-05-27

Product CodeOWI

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

LigaPASS™ System is the device name listed in this FDA 510(k) record. The listed applicant is Medicrea International S.A.S. It received FDA 510(k) clearance on 2026-05-27 under 510(k) number K261374. The device is classified under product code OWI. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LigaPASS™ System?

LigaPASS™ System is a medical device that received FDA 510(k) clearance on 2026-05-27. The listed applicant is Medicrea International S.A.S. The 510(k) number is K261374.

When did LigaPASS™ System receive FDA 510(k) clearance?

LigaPASS™ System received FDA 510(k) clearance on 2026-05-27, under 510(k) number K261374.

Who is the listed applicant for LigaPASS™ System?

The FDA 510(k) record lists Medicrea International S.A.S as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for LigaPASS™ System?

The FDA product code for LigaPASS™ System is OWI.

Related Devices (Code: OWI)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K253615Invictus Bands SystemAlphatec Spine, Inc.K222097OLYMPIC Deformity Band SystemAstura Medical K230565HILINE™ Fixation SystemGlobus Medical, Inc.K213659LigaPASS™ 2.0 Ligament Augmentation SystemMedicrea International SA K211057LigaPASS® Spinal System, CD Horizon™ Spinal SystemMedtronic, Inc.K201240Mariner Cap SystemSeaSpine Orthopedics Corporation

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.