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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 the device name listed in this FDA 510(k) record. The listed applicant is OSSIO , Ltd.. It received FDA 510(k) clearance on 2025-08-19 under 510(k) 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. The listed applicant is OSSIO , Ltd.. The 510(k) number is K252022.

When did OSSIOfiber® Interference Screw receive FDA 510(k) clearance?

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

Who is the listed applicant for OSSIOfiber® Interference Screw?

The FDA 510(k) record lists OSSIO , Ltd. as the applicant. This does not by itself establish the device manufacturer.

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

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

Other records listing OSSIO , Ltd. as applicant

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.

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Related Devices (Code: MAI)

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.

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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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