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FDA 510(k)

Biosteon® Screw

K-Number: K251680 · 2026-02-17

ApplicantBiocomposites, Ltd.
Decision Date2026-02-17
Product CodeMAI
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Biosteon® Screw is the device name listed in this FDA 510(k) record. The listed applicant is Biocomposites, Ltd.. It received FDA 510(k) clearance on 2026-02-17 under 510(k) number K251680. 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 Biosteon® Screw?

Biosteon® Screw is a medical device that received FDA 510(k) clearance on 2026-02-17. The listed applicant is Biocomposites, Ltd.. The 510(k) number is K251680.

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

Biosteon® Screw received FDA 510(k) clearance on 2026-02-17, under 510(k) number K251680.

Who is the listed applicant for Biosteon® Screw?

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

What is the FDA product code for Biosteon® Screw?

The FDA product code for Biosteon® Screw is MAI.

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Other records listing Biocomposites, Ltd. as applicant

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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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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