Predicate Research Report · generated 2026-08-21 · Print / save as PDF · Save to account
Spineway — Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
112 daysmedian FDA review time
125 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K231658 | VEOS Spinal Fixation System | Spineway | 2023-10-10 | 125 | 0 |
| K162694 | Ayers Rock Cervical interbody fusion system | Spineway | 2017-01-12 | 107 | 0 |
| K152355 | Twin Peaks Lumbar Interbody Fusion System | Spineway | 2015-12-10 | 112 | 0 |
| K150185 | Mont Blanc Spinal System | Spineway | 2015-05-12 | 105 | 0 |
| K150036 | Blue Mountain Cervical Plate System | Spineway | 2015-05-07 | 118 | 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