HKT Anatomical Locking Trauma System— 510(k) K254249
Substantially EquivalentHankil Tech Medical Co., Ltd.
FDA 510(k) clearance K254249 for HKT Anatomical Locking Trauma System, Substantially Equivalent on 2026-02-27. Applicant: Hankil Tech Medical Co., Ltd.. Device class: 2.
Summary
Hankil Tech Medical's HKT Anatomical Locking Trauma System is filed under product code HRS, bone fixation plate. The record doesn't describe the system beyond its name and that code name.
Class II, 21 CFR 888.3030. Orthopedic is both the classification panel and the review panel, and it came in as a Traditional 510(k).
Hankil Tech Medical filed from Hwaseong-Si, South Korea. The substantially equivalent decision came 60 calendar days after receipt (December 29, 2025 to February 27, 2026).
Clearance details
- Applicant
- Hankil Tech Medical Co., Ltd.
- Product code
- Product code HRS
- Device class
- Class 2
- Regulation
- 21 CFR 888.3030
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Hwaseong-Si, KR
Recent devices under product code HRS
view allMore clearances from Hankil Tech Medical Co., Ltd.
view allAdverse events under product code HRS
product code HRS- Death
- 27
- Injury
- 10,340
- Malfunction
- 3,328
- Total
- 13,695
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.