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FDA 510(k)

Arthrex Anatomic Lapidus Plates and I-Beam Lapidus Plates

K-Number: K252807 · 2026-01-12

ApplicantArthrex, Inc.
Decision Date2026-01-12
Product CodeHRS
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Arthrex Anatomic Lapidus Plates and I-Beam Lapidus Plates is the device name listed in this FDA 510(k) record. The listed applicant is Arthrex, Inc.. It received FDA 510(k) clearance on 2026-01-12 under 510(k) number K252807. The device is classified under product code HRS. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Arthrex Anatomic Lapidus Plates and I-Beam Lapidus Plates?

Arthrex Anatomic Lapidus Plates and I-Beam Lapidus Plates is a medical device that received FDA 510(k) clearance on 2026-01-12. The listed applicant is Arthrex, Inc.. The 510(k) number is K252807.

When did Arthrex Anatomic Lapidus Plates and I-Beam Lapidus Plates receive FDA 510(k) clearance?

Arthrex Anatomic Lapidus Plates and I-Beam Lapidus Plates received FDA 510(k) clearance on 2026-01-12, under 510(k) number K252807.

Who is the listed applicant for Arthrex Anatomic Lapidus Plates and I-Beam Lapidus Plates?

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

What is the FDA product code for Arthrex Anatomic Lapidus Plates and I-Beam Lapidus Plates?

The FDA product code for Arthrex Anatomic Lapidus Plates and I-Beam Lapidus Plates is HRS.

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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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