Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Tianjin Walkman Biomaterial 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) |
|---|---|---|---|---|---|
| K140229 | GENERAL SPINAL SYSTEM | Tianjin Walkman Biomaterial Co., Ltd. | 2014-04-29 | 89 | 0 |
| K132078 | METALLIC INTRAMEDULLARY NAIL SYSTEM | Tianjin Walkman Biomaterial Co., Ltd. | 2014-03-19 | 257 | 0 |
| K131759 | METALLIC LOCKING COMPRESSION BONE PLATES AND SCREWS SYSTEM | Tianjin Walkman Biomaterial Co., Ltd. | 2013-08-08 | 52 | 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