Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Shanghai Sanyou Medical Co, Ltd. · Predicate Candidate Screening
9 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
140 daysmedian FDA review time
309 days90th percentile
9clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K230872 | Halis™ Lumbar Cage System, Lydia™ Anterior Lumbar Fusion Sys | Shanghai Sanyou Medical Co, Ltd. | 2023-12-12 | 257 | 0 |
| K230961 | Zeus Spinal System | Shanghai Sanyou Medical Co, Ltd. | 2023-10-10 | 188 | 0 |
| K231931 | Adena-Zina Spinal System | Shanghai Sanyou Medical Co, Ltd. | 2023-07-28 | 28 | 0 |
| K211689 | KEYSTONE PEEK Cage System | Shanghai Sanyou Medical Co, Ltd. | 2021-09-21 | 111 | 0 |
| K212066 | Adena-Zina System | Shanghai Sanyou Medical Co, Ltd. | 2021-08-16 | 45 | 0 |
| K163366 | Shanghai Sanyou CARMEN Cervical Fusion System | Shanghai Sanyou Medical Co, Ltd. | 2017-10-05 | 309 | 0 |
| K163422 | Shanghai Sanyou PEEK Cage System | Shanghai Sanyou Medical Co, Ltd. | 2017-09-18 | 286 | 0 |
| K152781 | Adena-Zina System | Shanghai Sanyou Medical Co, Ltd. | 2016-02-12 | 140 | 0 |
| K131512 | KATIA SYSTEM | Shanghai Sanyou Medical Co, Ltd. | 2013-08-07 | 71 | 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