Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Coalign Innovations, Inc. — Predicate Candidate Screening
9 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
39 daysmedian FDA review time
132 days90th percentile
9clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K132505 | ACCULIF TL AND PL CAGE | Coalign Innovations, Inc. | 2013-09-12 | 31 | 0 |
| K131443 | COALIGN INNOVATIONS ACCULIF XL IBF CAGE | Coalign Innovations, Inc. | 2013-06-19 | 30 | 0 |
| K130194 | ACCULIF XL CAGE | Coalign Innovations, Inc. | 2013-04-03 | 65 | 0 |
| K123281 | ACCULIF TL-PEEK CAGE | Coalign Innovations, Inc. | 2013-01-23 | 93 | 0 |
| K123752 | ACCULIF TL AND PL CAGE | Coalign Innovations, Inc. | 2013-01-14 | 39 | 0 |
| K121683 | ACCULIF TL CAGE | Coalign Innovations, Inc. | 2012-07-05 | 28 | 0 |
| K113465 | ACCULIF TL CAGE | Coalign Innovations, Inc. | 2011-12-12 | 20 | 0 |
| K112095 | ACCULIF TL-PEEK IBF CAGE | Coalign Innovations, Inc. | 2011-12-01 | 132 | 0 |
| K110270 | ACCULIF CAGE | Coalign Innovations, Inc. | 2011-04-07 | 66 | 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