APS Spear Locking Plate— 510(k) K254053
Substantially EquivalentA Plus Biotechnology Co., Ltd.
FDA 510(k) clearance K254053 for APS Spear Locking Plate, Substantially Equivalent on 2026-03-17. Applicant: A Plus Biotechnology Co., Ltd.. Device class: 2.
Summary
A Plus Biotechnology's APS Spear Locking Plate is filed under HRS, bone fixation plates. The record doesn't list plate sizes or shapes.
Class II, 21 CFR 888.3030. Orthopedic is both the classification panel and the review panel. It was a Traditional 510(k).
A Plus Biotechnology filed from New Taipei City, Taiwan. The decision came 90 calendar days after receipt (December 17, 2025 to March 17, 2026).
Clearance details
- Applicant
- A Plus Biotechnology 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
- New Taipei City, TW
Recent devices under product code HRS
view allMore clearances from A Plus Biotechnology 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.