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FDA 510(k)

OSSIOfiber® Suture Anchor

K-Number: K254055 · 2026-02-24

ApplicantOSSIO , Ltd.
Decision Date2026-02-24
Product CodeMAI
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

OSSIOfiber® Suture Anchor is the device name listed in this FDA 510(k) record. The listed applicant is OSSIO , Ltd.. It received FDA 510(k) clearance on 2026-02-24 under 510(k) number K254055. 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?

OSSIOfiber® Suture Anchor is a medical device that received FDA 510(k) clearance on 2026-02-24. The listed applicant is OSSIO , Ltd.. The 510(k) number is K254055.

When did OSSIOfiber® Suture Anchor receive FDA 510(k) clearance?

OSSIOfiber® Suture Anchor received FDA 510(k) clearance on 2026-02-24, under 510(k) number K254055.

Who is the listed applicant for OSSIOfiber® Suture Anchor?

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® Suture Anchor?

The FDA product code for OSSIOfiber® Suture Anchor 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.

K254077OSSIOfiber® Threaded Trimmable Fixation NailK252022OSSIOfiber® Interference ScrewK251309OSSIOfiber® Suture AnchorK243760OSSIOfiber® Suture Anchor 2.5-3.5 mmK241932OSSIOfiber® Compression StapleK241277OSSIOfiber® Threaded Trimmable Fixation Nail

View all 20 devices →

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.

K262357Arthrex Bioabsorbable PushLock Suture AnchorsArthrex, Inc.K253931Arthrex Bioabsorbable PushLock Suture AnchorsArthrex, Inc.K260294SF Push-in AnchorSurgical Fusion Technologies GmbHK251680Biosteon® ScrewBiocomposites, Ltd.K252946BioBrace® Extra-Articular Ligament Augmentation KitConmed CorporationK252022OSSIOfiber® Interference ScrewOSSIO , Ltd.

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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