Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Surgalign Spine Technologies — Predicate Candidate Screening
3 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K231611 | HOLO Portalâ„¢ Surgical Guidance System | Surgalign Spine Technologies | 2023-08-31 | 90 | 0 |
| K221403 | Cortera Spinal Fixation System | Surgalign Spine Technologies | 2022-08-19 | 95 | 2 |
| K211254 | ARAI Surgical Navigation System | Surgalign Spine Technologies | 2022-01-14 | 263 | 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