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FDA 510(k)

OSSIOfiber® Suture Anchor 2.5-3.5 mm

K-Number: K243760 · 2025-04-03

ApplicantOSSIO , Ltd.
Decision Date2025-04-03
Product CodeMAI
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

OSSIOfiber® Suture Anchor 2.5-3.5 mm is a medical device manufactured by OSSIO , Ltd.. It received FDA 510(k) clearance on 2025-04-03 under approval number K243760. The device is classified under product code MAI. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OSSIOfiber® Suture Anchor 2.5-3.5 mm?

OSSIOfiber® Suture Anchor 2.5-3.5 mm is a medical device that received FDA 510(k) clearance on 2025-04-03. It is manufactured by OSSIO , Ltd.. The 510(k) number is K243760.

When was OSSIOfiber® Suture Anchor 2.5-3.5 mm approved by the FDA?

OSSIOfiber® Suture Anchor 2.5-3.5 mm received FDA 510(k) clearance on 2025-04-03, under approval number K243760.

What company makes OSSIOfiber® Suture Anchor 2.5-3.5 mm?

OSSIOfiber® Suture Anchor 2.5-3.5 mm is manufactured by OSSIO , Ltd..

What is the FDA product code for OSSIOfiber® Suture Anchor 2.5-3.5 mm?

The FDA product code for OSSIOfiber® Suture Anchor 2.5-3.5 mm is MAI.

Related PubMed Literature

PMID: 40868376 Correlation Analysis of Suture Anchor Pull-Out Strength with Cortical Bone Thickness and Cancellous Bone Density on a Finite Element Model. Bioengineering (Basel, Switzerland) (2025)

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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.

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