Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Cardinal Spine, LLC — Predicate Candidate Screening
4 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K152568 | C-VBR | Cardinal Spine, LLC | 2016-02-11 | 155 | 0 |
| K142030 | STGC-LORDOTIC | Cardinal Spine, LLC | 2015-01-23 | 182 | 0 |
| K121176 | STGC | Cardinal Spine, LLC | 2012-08-17 | 121 | 0 |
| K100698 | STCC | Cardinal Spine, LLC | 2011-03-14 | 368 | 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