Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
A Plus Biotechnology Co., Ltd. — Predicate Candidate Screening
3 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K254053 | APS Spear Locking Plate | A Plus Biotechnology Co., Ltd. | 2026-03-17 | 90 | 0 |
| K252897 | APS Osteotomy Fixation System (0945-1302-xx /4.5mm Cortex Sc | A Plus Biotechnology Co., Ltd. | 2025-12-11 | 91 | 0 |
| K223150 | APS Metal Plate & Screw System | A Plus Biotechnology Co., Ltd. | 2023-08-24 | 323 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda