Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
ZSFab, Inc. — Predicate Candidate Screening
6 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
99 daysmedian FDA review time
129 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K261451 | ZSAlign Cervical Interbody System | ZSFab, Inc. | 2026-07-31 | 91 | 0 |
| K260549 | ZSFab Cervical Interbody System and ZSFab Lumbar Interbody S | Zsfab, Inc. | 2026-04-24 | 65 | 0 |
| K252610 | ZSFab Lumbar Interbody System | Zsfab, Inc. | 2025-11-25 | 99 | 0 |
| K232150 | ZSFab Cervical Interbody System | Zsfab, Inc. | 2023-08-18 | 30 | 0 |
| K221858 | ZSFab Lumbar Interbody System | Zsfab, Inc. | 2022-10-14 | 109 | 0 |
| K202488 | ZSFab Cervical Interbody System | Zsfab, Inc. | 2021-01-07 | 129 | 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