K254053
- 510(k) number
- K254053
- Device name
- APS Spear Locking Plate
- Applicant
- A Plus Biotechnology Co., Ltd. TW
- Product code
- HRS — Plate, Fixation, Bone
- Decision date
- 2026-03-17
- Date received
- 2025-12-17
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Orthopedic
PDFDownload 510(k) SummaryArchived here · 0.9 MB · U.S. public domain
Also available from FDA: K254053.pdf
Official FDA record: K254053
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.