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FDA 510(k)

SMART Osteotomy System

K-Number: K260090 · 2026-04-10

ApplicantActis Medical Pty., Ltd.
Decision Date2026-04-10
Product CodeHRS
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

SMART Osteotomy System is the device name listed in this FDA 510(k) record. The listed applicant is Actis Medical Pty., Ltd.. It received FDA 510(k) clearance on 2026-04-10 under 510(k) number K260090. 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 SMART Osteotomy System?

SMART Osteotomy System is a medical device that received FDA 510(k) clearance on 2026-04-10. The listed applicant is Actis Medical Pty., Ltd.. The 510(k) number is K260090.

When did SMART Osteotomy System receive FDA 510(k) clearance?

SMART Osteotomy System received FDA 510(k) clearance on 2026-04-10, under 510(k) number K260090.

Who is the listed applicant for SMART Osteotomy System?

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

What is the FDA product code for SMART Osteotomy System?

The FDA product code for SMART Osteotomy System is HRS.

Related Devices (Code: HRS)

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.

K260277MIKRON TRAUMA BONE PLATE& SCREW SYSTEMMikron Makina San. ve Tic. Ltd. Sti.K261511Xpert AnkleNewclip TechnicsK261406Versalock Proximal Tibial Plating SystemGM Dos Reis Industria e Comercio Ltda.K262032TriMed Non-Spanning Wrist Fusion Plates (NSFL-STD);TriMed Non-Spanning Wrist Fusion Plates (NSFR-STD);TriMed Non-Spanning Wrist Fusion Plates (NSFL-SHB );TriMed Non-Spanning Wrist Fusion Plates (NSFR-SHB )TriMed, Inc.K261191Alians Elbow SNewclip TechnicsK261054RibPlate SystemStryker Leibinger GmbH & Co KG

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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