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FDA 510(k)

OSSIOfiber® Interference Screw

K-Number: K252022 · 2025-08-19

ApplicantOSSIO , Ltd.
Decision Date2025-08-19
Product CodeMAI
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

OSSIOfiber® Interference Screw is a medical device manufactured by OSSIO , Ltd.. It received FDA 510(k) clearance on 2025-08-19 under approval number K252022. 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® Interference Screw?

OSSIOfiber® Interference Screw is a medical device that received FDA 510(k) clearance on 2025-08-19. It is manufactured by OSSIO , Ltd.. The 510(k) number is K252022.

When was OSSIOfiber® Interference Screw approved by the FDA?

OSSIOfiber® Interference Screw received FDA 510(k) clearance on 2025-08-19, under approval number K252022.

What company makes OSSIOfiber® Interference Screw?

OSSIOfiber® Interference Screw is manufactured by OSSIO , Ltd..

What is the FDA product code for OSSIOfiber® Interference Screw?

The FDA product code for OSSIOfiber® Interference Screw is MAI.

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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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