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FDA 510(k)

LigaPASS™ 2.0 Ligament Augmentation System

K-Number: K213659 · 2022-05-24

ApplicantMedicrea International SA
Decision Date2022-05-24
Product CodeOWI
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

LigaPASS™ 2.0 Ligament Augmentation System is the device name listed in this FDA 510(k) record. The listed applicant is Medicrea International SA. It received FDA 510(k) clearance on 2022-05-24 under 510(k) number K213659. 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™ 2.0 Ligament Augmentation System?

LigaPASS™ 2.0 Ligament Augmentation System is a medical device that received FDA 510(k) clearance on 2022-05-24. The listed applicant is Medicrea International SA. The 510(k) number is K213659.

When did LigaPASS™ 2.0 Ligament Augmentation System receive FDA 510(k) clearance?

LigaPASS™ 2.0 Ligament Augmentation System received FDA 510(k) clearance on 2022-05-24, under 510(k) number K213659.

Who is the listed applicant for LigaPASS™ 2.0 Ligament Augmentation System?

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

What is the FDA product code for LigaPASS™ 2.0 Ligament Augmentation System?

The FDA product code for LigaPASS™ 2.0 Ligament Augmentation System is OWI.

Other records listing Medicrea International SA as applicant

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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.

K261374LigaPASS™ SystemMedicrea International S.A.SK253615Invictus Bands SystemAlphatec Spine, Inc.K222097OLYMPIC Deformity Band SystemAstura MedicalK230565HILINE™ Fixation SystemGlobus Medical, Inc.K211057LigaPASS® Spinal System, CD Horizon™ Spinal SystemMedtronic, Inc.K201240Mariner Cap SystemSeaSpine Orthopedics Corporation

Official Source

View on FDA Database →

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

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