Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Spineworks, 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) |
|---|---|---|---|---|---|
| K133340 | SPINEWORKS ANTERIOR LUMBAR DEVICE | Spineworks, LLC | 2014-04-11 | 163 | 0 |
| K111166 | A-WEDGE ANTERIOR INTERBODY SYSTEM (A-WEDGE A.I.S.) | Spineworks, LLC | 2011-09-08 | 135 | 0 |
| K081331 | FIXXSURE CROSS LINK | Spineworks, LLC | 2008-07-23 | 72 | 0 |
| K042600 | STANSION MATRIX | Spineworks, LLC | 2005-02-18 | 148 | 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