FDA 510(k)

LigaPASS 2.0 Ligament Augmentation System

K-Number: K213659 · 2022-05-24

Decision Date2022-05-24

Product CodeOWI

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

LigaPASS 2.0 Ligament Augmentation System is a medical device manufactured by Medicrea International SA. It received FDA 510(k) clearance on 2022-05-24 under approval 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. It is manufactured by Medicrea International SA. The 510(k) number is K213659.

When was LigaPASS 2.0 Ligament Augmentation System approved by the FDA?

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

What company makes LigaPASS 2.0 Ligament Augmentation System?

LigaPASS 2.0 Ligament Augmentation System is manufactured by Medicrea International SA.

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.

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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.