Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Trauson (Jiangsu) Medical Instrument Co., Ltd. · Predicate Candidate Screening
4 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K082617 | TRAUSON GENERAL SPINAL SYSTEM (GSS) | Trauson (Jiangsu) Medical Instrument Co., Ltd. | 2009-01-15 | 128 | 0 |
| K081230 | TRAUSON INTRAMEDULLARY NAIL | Trauson (Jiangsu) Medical Instrument Co., Ltd. | 2009-01-13 | 258 | 0 |
| K073432 | TRAUSON BONE PLATE | Trauson (Jiangsu) Medical Instrument Co., Ltd. | 2008-08-13 | 251 | 0 |
| K073159 | TRAUSON BONE SCREW, MODELS HA 3.5 AND 4.5 | Trauson (Jiangsu) Medical Instrument Co., Ltd. | 2008-07-23 | 258 | 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