Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Weigao Orthopaedic Device Co., Ltd. — Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
176 daysmedian FDA review time
291 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K133053 | MILESTONE SPINAL SYSTEM | Weigao Orthopaedic Device Co., Ltd. | 2014-07-15 | 291 | 0 |
| K122994 | INTRAMEDULLARY NAIL SYSTEM | Weigao Orthopaedic Device Co., Ltd. | 2013-04-12 | 197 | 0 |
| K130340 | LOCKING BONE PLATES AND SCREWS | Weigao Orthopaedic Device Co., Ltd. | 2013-04-05 | 53 | 0 |
| K123578 | ANTERIOR CERVICAL PLATE SYSTEM | Weigao Orthopaedic Device Co., Ltd. | 2013-02-01 | 73 | 0 |
| K121312 | INTRAMEDULLARY NAIL SYSTEM | Weigao Orthopaedic Device Co., Ltd. | 2012-10-24 | 176 | 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