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FDA 510(k)

HKT Anatomical Locking Trauma System

K-Number: K254249 · 2026-02-27

ApplicantHankil Tech Medical Co., Ltd.
Decision Date2026-02-27
Product CodeHRS
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

HKT Anatomical Locking Trauma System is a medical device manufactured by Hankil Tech Medical Co., Ltd.. It received FDA 510(k) clearance on 2026-02-27 under approval number K254249. 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 HKT Anatomical Locking Trauma System?

HKT Anatomical Locking Trauma System is a medical device that received FDA 510(k) clearance on 2026-02-27. It is manufactured by Hankil Tech Medical Co., Ltd.. The 510(k) number is K254249.

When was HKT Anatomical Locking Trauma System approved by the FDA?

HKT Anatomical Locking Trauma System received FDA 510(k) clearance on 2026-02-27, under approval number K254249.

What company makes HKT Anatomical Locking Trauma System?

HKT Anatomical Locking Trauma System is manufactured by Hankil Tech Medical Co., Ltd..

What is the FDA product code for HKT Anatomical Locking Trauma System?

The FDA product code for HKT Anatomical Locking Trauma System is HRS.

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Related PubMed Literature

PMID: 40775988 B-onic Suite: An Integrated Platform for Personalized Medical Devices, Real-Time Surgical Planning, and Enhanced Intraoperative Navigation. Studies in health technology and informatics (2025)

Other Devices by Hankil Tech Medical Co., Ltd.

K231213HKT Anatomical Locking Trauma System

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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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