Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Aegis Spine, Inc. · Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
58 daysmedian FDA review time
143 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K223521 | ZESPIN SI Joint Fusion System | Aegis Spine, Inc. | 2023-01-20 | 58 | 0 |
| K223719 | Paeon Anterior Cervical Plate System, Elatus Lumbar Plate Sy | Aegis Spine, Inc. | 2023-01-11 | 30 | 0 |
| K221719 | ABTross ALIF Expandable Cage System | Aegis Spine, Inc. | 2022-11-03 | 143 | 0 |
| K221050 | ZESPIN SI Joint Fusion System, Paeon Posterior Cervical Fixa | Aegis Spine, Inc. | 2022-06-30 | 80 | 0 |
| K203531 | XYPAN Expandable Lumbar Cage System | Aegis Spine, Inc. | 2021-01-29 | 58 | 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