Clearance Summary
HKT Anatomical Locking Trauma System received FDA 510(k) clearance under submission number K254249, sponsored by Hankil Tech Medical Co., Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Orthopedic review panel. The statutory decision date of record is 2026-02-27.
- Submission: K254249
- Applicant / Sponsor: Hankil Tech Medical Co., Ltd.
- Clearance pathway: Traditional
- Review panel: Orthopedic
- Device class: Class II
- Regulation citation: 21 CFR 888.3030
- Decision date: 2026-02-27
Classification & Regulation
This clearance is catalogued under FDA product code HRS and 21 CFR 888.3030, within the Orthopedic review panel as a Class II device.