Clearance Summary
APS Spear Locking Plate received FDA 510(k) clearance under submission number K254053, sponsored by A Plus Biotechnology 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 2026-03-17.
- Submission: K254053
- Applicant / Sponsor: A Plus Biotechnology Co., Ltd.
- Clearance pathway: Traditional
- Review panel: Orthopedic
- Device class: Class II
- Regulation citation: 21 CFR 888.3030
- Decision date: 2026-03-17
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.