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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 a medical device manufactured by Actis Medical Pty., Ltd.. It received FDA 510(k) clearance on 2026-04-10 under approval 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. It is manufactured by Actis Medical Pty., Ltd.. The 510(k) number is K260090.

When was SMART Osteotomy System approved by the FDA?

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

What company makes SMART Osteotomy System?

SMART Osteotomy System is manufactured by Actis Medical Pty., Ltd..

What is the FDA product code for SMART Osteotomy System?

The FDA product code for SMART Osteotomy System 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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