Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Innosys 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) |
|---|---|---|---|---|---|
| K241082 | INNOVERSE Navigation Instruments | Innosys Co., Ltd. | 2024-06-14 | 56 | 0 |
| K234119 | UniSpace® Stand-Alone C Cage | Innosys Co., Ltd. | 2024-04-19 | 113 | 0 |
| K233960 | INNOVERSE Spinal System | Innosys Co., Ltd. | 2024-02-06 | 53 | 0 |
| K231737 | ANAX™ 5.5 Spinal System | Innosys Co., Ltd. | 2023-10-26 | 134 | 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